NobelZygoma TiUltra Implant system

K243834 · Nobel Biocare AB · DZE · Aug 25, 2025 · Dental

Device Facts

Record IDK243834
Device NameNobelZygoma TiUltra Implant system
ApplicantNobel Biocare AB
Product CodeDZE · Dental
Decision DateAug 25, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

Device Story

System comprises NobelZygoma TiUltra implants, Multi-unit Abutments (MUA) Xeal Zygoma, and fixation screws. Implants are surgically placed into zygomatic bone to support dental prostheses in edentulous/partially edentulous maxillae. Implants feature unalloyed titanium grade 4 construction, two-level anodized surface (Xeal/spark-anodized), and soluble salt layer for surface preservation. MUAs connect to implants to support screw-retained restorations; available in various angulations (0°, 17°, 45°, 60°). Screws fasten components to implants. Used in clinical dental settings by trained clinicians. Output is a stable foundation for prosthetic rehabilitation, restoring chewing function and esthetics. Benefits include multi-point support in severe bone resorption cases, enabling immediate loading protocols.

Clinical Evidence

Evidence includes systematic literature reviews, clinical studies, and post-market surveillance. Literature review of 176 zygomatic implants showed 97.4% survival for quad configurations. Two clinical studies (n=317) reported survival rates of 100% and 89.9%. 40 publications support safe clinical history of zygomatic implants. Post-market data (July 2024-May 2025) shows complaint rates comparable to predicate TiUnite implants. Clinical cases (n=16) reported no complications. Data on TiUltra family supports surface treatment safety.

Technological Characteristics

Materials: Unalloyed titanium grade 4 (ASTM F67) for implants; Ti-6Al-4V (ASTM F136) for abutments/screws. Surface: Anodic oxidation (anodization) with soluble salt (protective) layer. Design: Parallel-walled, threaded apex, 30-60mm lengths. Connection: External hex or conical connection. Sterilization: Gamma (SAL 10^-6). Connectivity: Standalone prosthetic system.

Indications for Use

Indicated for patients with severe maxillary bone resorption requiring dental prosthesis support in the upper arch. Appropriate for immediate loading given sufficient primary stability. Contraindications not explicitly listed beyond standard surgical/prosthetic requirements.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION August 25, 2025 Nobel Biocare AB Bernice Jim Head of RA Development Implant systems, US/CA &amp; PLM, Strategy &amp; EBS Vastra Hamngatan 1 Goteborg, Vastra SE 411 17 SWEDEN Re: K243834 Trade/Device Name: NobelZygoma TiUltra Implant system Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 12, 2024 Received: July 23, 2025 Dear Bernice Jim: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243834 – Bernice Jim Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K243834 – Bernice Jim Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Sherrill Lathrop Blitzer for Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use Submission Number (if known) K243834 Device Name NobelZygoma TiUltra Implant system Indications for Use (Describe) NobelZygoma TiUltra implants The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Multi-Unite Abutment Xeal Zygoma The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.” {4} K243834 N Nobel Biocare # 1 510(k) Summary ## 1.1 Submitter Information Submitter: Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland Contact Person: Bernice Jim, Ph.D E-Mail: regulatory.affairs.nb@envistaco.com Telephone Number: +41 43 211 42 00 Prepared By: Ana Sala Roca, Ph.D. Date Prepared: August 22nd, 2025 Page 1 of 35 {5} N Nobel Biocare ## 1.2 Device Name and Classification Proprietary name: NobelZygoma TiUltra Implant system Manufacturer: Nobel Biocare AB Common Name: Dental Implant Classification Name: Endosseous Dental Implant Regulation Number: 21 CFR 872.3640 Device Class: II Primary Product Code: DZE Secondary Product Code: NHA ## 1.3 Predicate Devices ### Primary Predicate Device K152093, NobelZygoma 45° TiUnite, Nobel Biocare AB ### Reference Device: Reference Device #1: K161598, NobelZygoma 0° TiUnite, Nobel Biocare AB Reference Device #2: K222497, Zaga Zygomatic system, Southern Implants (Pty) Ltd Reference Device #3: K151909, Noris Medical Zygomatic Dental Implant, Noris Medical Reference Device #4: K050641, Brånemark System Zygoma Multi-Unit Abutment, Nobel Biocare AB Reference Device #5: K052885, Brånemark System Zygoma 17° Multi-unit Abutment, Nobel Biocare AB Reference Device #6: K161598, Multi-unit Abutment Ext Hex, Nobel Biocare AB Reference Device #7: K202344, NobelParallel CC TiUltra Implants, Nobel Biocare AB Reference Device #8: K202344, Multi-unit Abutment Xeal Conical Connection, Nobel Biocare AB Page 2 of 35 {6} Nobel Biocare ## 1.4 Device Description Summary The Subject Device NobelZygoma TiUltra Implant system is composed of three device lines: NobelZygoma TiUltra Implants, Multi-unit Abutments Xeal Zygoma and NobelZygoma Multi-unit Abutment Xeal Zygoma Screws. The **NobelZygoma TiUltra Implants** are endosseous dental implants surgically placed in the zygomatic bone to provide support for prosthetic devices. They are used with patients with severe bone resorption in the maxilla to provide multi-point support of the dental reconstruction. The NobelZygoma TiUltra Implants are used to support the rehabilitation of a fully or a partially edentulous maxilla. The Subject Devices are only intended for extra-maxillary placement. The subject Implants are made from unalloyed titanium grade 4 (ASTM F67) and present a two-level anodized surface with a soluble salt (protective) layer. Two variants of the Implants are available based on the collar angulation: the NobelZygoma 0° and the NobelZygoma 45° TiUltra Implants. The NobelZygoma 0° CC TiUltra Implants feature a conical connection platform with an internal hex (size RP). The NobelZygoma 45° Ext Hex TiUltra Implants include an external hexagonal platform (size RP). The NobelZygoma TiUltra implants are available in lengths ranging from 30 mm to 60 mm, in 2.5 mm increments. They feature a partially threaded design. The neck portion, measuring 3.6 mm from the platform, and the shaft portion which varies depending on the implant length, are unthreaded. For all implant lengths, threading consistently begins at the apex and extends 18 mm coronally. The NobelZygoma TiUltra Implants are co-packed with an implant mount, which is attached via a pre-assembled implant mount screw to the platform of the implant. The **Multi-unit Abutments Xeal Zygoma** are premanufactured prosthetic components intended to be connected to the compatible NobelZygoma TiUltra Implants to support the placement of a dental prosthesis. The Multi-unit Abutment (MUA) Xeal Zygoma are made from Titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and feature a non-porous oxide layer with a soluble salt (protective) layer. The Multi-unit Abutments Xeal Zygoma are attached to the respective NobelZygoma TiUltra Implants by the compatible NobelZygoma Multi-unit Abutment Xeal Zygoma Screw. The Multi-unit Abutment Xeal Zygoma are available in four different angulations (straight or 0°, 17°, 45° and 60°) and in different heights ranging from 3 to 9 mm (2 mm increase). The 45° and 60° angulations are used with the NobelZygoma 0° TiUltra implants, while Page 3 of 35 {7} N Nobel Biocare the Straight (or 0°) and 17° angulations are compatible with the NobelZygoma 45° TiUltra Implants. The 17° MUA is only available in two heights (3 and 5mm). The Multi-unit Abutments Xeal Zygoma are provided sterile and co-packed with the respective abutment handle and NobelZygoma Multi-Unit Abutments Xeal Zygoma Screw. The **NobelZygoma Multi-unit Abutment Xeal Zygoma Screws** are dental implant screws designed to fasten dental implant system components to a dental implant or to another component. The subject screws are made of titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and are partially DLC-coated. They are available in different design and sizes to fit the different Multi-unit Abutments Xeal Zygoma. The Straight NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are available in four sizes to fit the respective Straight Multi-Unit Abutment heights. The screws for the 45°/60° Multi-Unit Abutments and the 17° Multi-Unit Abutment are only available in one size that fits all abutment sizes. The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are co-packed with the compatible Multi-unit Abutment Xeal Zygoma and are also available separately. ## 1.5 Intended Use/Indication for Use The **NobelZygoma TiUltra Implants** are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The **Multi-unit Abutments Xeal Zygoma** are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. The **NobelZygoma Multi-Unit Abutment Screws** are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. ## 1.6 Indications for Use Comparison The Intended Use statement and Indications for Use statement are the same, expressed through a similar choice of words. Page 4 of 35 {8} N Nobel Biocare™ # 1.7 Technological Comparison # 1.7.1 Substantial Equivalence Table - NobelZygoma $45^{\circ}$ Ext Hex TiUltra Implants | | Subject Device NobelZygoma 45° Ext Hex TiUltra | Primary Predicate Device NobelZygoma 45° implants | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | 510(k) | K243834 | K152093 | K222497 | K151909 | K202344 | N/A | | Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Southern Implants (Pty) Ltd | Noris Medical | Nobel Biocare AB | N/A | | Representativ e Image(s) | | | | | | N/A | | Regulatory Aspects | | | | | | | | Product Classification | Class II | Class II | Class II | Class II | Class II | Same as Primary Predicate. | | Regulatory Number / Name | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | Same as Primary Predicate. | | Product Code | DZE | DZE | DZE | DZE (NHA) | DZE | Same as Primary Predicate. | | Review Panel | Dental | Dental | Dental | Dental | Dental | Same as Primary Predicate. | | Intended Use and Indications for Use | | | | | | | | Intended Use | NobelZygoma TiUltra implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. | NobelZygoma 45° implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. | Functional and esthetic rehabilitation of the edentulous maxilla | Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate | Nobel Biocare's TiUltra implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. | Same as Primary Predicate. Same as Reference Device #2 and Reference Device #3 with differences in choice of words. | {9} N Nobel Biocare™ | | Subject Device NobelZygoma 45° Ext Hex TiUltra | Primary Predicate Device NobelZygoma 45° implants | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | Indications for Use^{1} | NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | NobelZygoma 45 implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied. | Straumann® Zygomatic implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae. | NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jawbone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7mm length are for delayed loading only when appropriate stability has been achieved. | Same as Primary Predicate with minor differences in choice of words in alignment with Reference Device #1. Same as Reference Device #2 and Reference Device #3 with differences in choice of words. | | Placement Method | Extra-maxillary | Inside or outside the maxillary sinus | Inside or outside the maxillary sinus | Extra-maxillary | N/A | Same as Reference Device #3 | | Technological Characteristics | | | | | | | | Device Dimensions / Design Specifications | | | | | | | | Implant Length (length as per label) | 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm | 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50 and 52.5mm | ZAGA Round: 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm ZAGA Flat: 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5mm | 7, 8.5, 10, 11.5, 13, 15, 18mm | Similar to Primary Predicate. Same range of lengths as the Reference Device #2. | Page 6 of 35 {10} N Nobel Biocare™ | | Subject Device NobelZygoma 45° Ext Hex TiUltra | Primary Predicate Device NobelZygoma 45° implants | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | Implant Diameter | Implant neck: Ø 4.3mm Shaft: Ø 3.9mm Apical thread diameter: Ø 3.9mm | Implant neck: Ø 4.5mm Shaft: Ø 3.95mm Apical thread diameter: Ø 3.9mm | ZAGA round: 4.3 mm (coronal) taper to 3.4 mm (apical) ZAFA flat: 4.3 mm (coronal with 3.35 mm flat) taper to 3.4 mm (apical) | 4.2mm (4.2 max diameter body, 3.5 apex) | 3.75, 4.3, 5.0, 5.5mm | Similar to Primary Predicate. | | Platform Compatibility | Regular Platform (RP) | Regular Platform (RP) | 4.07mm | 3.75mm (4.2mm neck Ø) | Narrow Platform (NP) Regular Platform (RP) Wide Platform (WP) | Same as Primary Predicate. | | Connection Type | External Hex Connection | External Hex Connection | External Hex Connection | Internal conical connection (with internal hex) | Internal conical connection with hex interface | Same as Primary Predicate. | | Implant Platform Angulation (relative to implant axis) | 45° angulation at head of implant | 45° angulation at head of implant | 55° angulation at head of implant | (straight) 0° angulation at head of implant | (straight) 0° angulation at head of implant | Same as Primary Predicate. | | Angulation of compatible Abutments | Straight (no angulated or 0°) and 17° Zygoma Abutments | Straight (no angulated or 0°) and 17° Zygoma Abutments | Straight (no angulated or 0°) | 17°, 30°, 45° (extended at 52° and 60° with K210356) | Straight (no angulated or 0°), 17° and 30° | Same as Primary Predicate | | Thread Design | Single helix 60° V shape thread form, length 18mm Thread pitch: 0.6mm | Single helix 60° V shape thread form, length 18mm Thread pitch: 0.6mm | Partially threaded root-form implants for placement into the zygoma. Round and machined apex with a thread pitch of 0.8mm | Tapered Screw type (length 13mm) Thread pitch: 1.295 | Double lead thread with groove | Same as Primary Predicate. | | Implant Tip Design | Tapered apex with cut out flutes | Tapered apex with cut out flutes | Tapered with cut out flutes | Double thread, double flutes | Tapered apex with cut out flutes | Same as Primary Predicate. | | Material | Unalloyed titanium grade 4 (ASTM F67) (Implant mount & implant mount screw: titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) according to ASTM F136). | Unalloyed titanium grade 4 (ASTM F67) (Implant mount: unalloyed titanium grade 1 (ASTM F67) & Implant mount screw: titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) according to ASTM F136. DLC coating.) | Unalloyed titanium grade 4 (ASTM F67), and UTS ≥ 900Mpa (cold-worked) | Titanium alloy Ti 6Al 4V ELI | Unalloyed titanium grade 4 (ASTM F67) | Same materials as Primary Predicate. | | Surface Treatment | Anodic oxidation (anodization) | Anodic oxidation (anodization) | Grit-blasted | -machined surface at the coronal/shaft region -resorbable blast media (distal Surface/threaded apex) | Anodic oxidation (anodization) | The Subject Device, the Primary Predicate and the Reference Device #7 present an anodic anodized surface. The Subject Device at the collar/shaft present the same | Page 7 of 35 {11} N Nobel Biocare™ | | Subject Device NobelZygoma 45° Ext Hex TiUltra | Primary Predicate Device NobelZygoma 45° implants | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | | | | | | | Xeal anodized surface as the Level 0 (collar) of the Reference Device #7. The Reference Device #3 presents a machined surface at the collar/shaft. | | Surface Topography | TiUltra - two level surface: Level 1 (shaft and coronal part): Xeal yellow anodization - Sa (area roughness) = 0.5± 0.3μm - Thickness = 0.17±0.01μm Level 2 (threaded apex): Spark-anodized - Sa = 1.5 ± 0.4μm - Thickness = 12.0±1.2μm | TiUnite – single level surface: - Sa = 1.2 ± 0.5μm - Thickness = 12.5 ± 2.5μm | --- | Collar/Shaft (Level 1) - surface roughness total average: - Sa (area roughness) = ca. 0.27μm | TiUltra – three level surface: Level 0 (collar): Xeal yellow anodization Sa=0.5±0.3μm Thickness = 0.17±0.01μm Level 1 (transition): Spark-anodized - Roughness: Sa=0.8±0.3μm - Thickness: 7.5 ± 0.3μm Level 2 (body/apex): Spark-anodized Sa = 1.5 ± 0.4μm Thickness = 12.0 ± 1.2μm | The surface roughness of the Subject Device at Level 1 (collar/shaft) is between the surface roughness of the Primary Predicate and the Reference Device #3. Same Surface technology as Reference Device #7 but featuring two levels instead of three levels. | | Surface Preservation | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on apex, shaft, and collar (excluding connection/ platform). Concentration: 0.1-200μg/cm² | None | None | None | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on apex, shaft, and collar (excluding connection/ platform). Concentration: 0.1- 200μg/cm² | Same soluble salt (protective layer) as Reference Device #7. | | Packaging, Sterility, Shelf-Life, Anatomical Location and Use | | | | | | | | Sterile at supply | Yes (Gamma sterilization; SAL 10⁻⁶) | Yes (Gamma sterilization; SAL 10⁻⁶) | Yes (Gamma sterilization) | Yes (Gamma sterilization) | Yes (Gamma sterilization; SAL 10⁶) | Same as Primary Predicate. | | Initial processing needed | No | No | No | No | No | Same as Primary Predicate. | Page 8 of 35 {12} N Nobel Biocare™ | | Subject Device NobelZygoma 45° Ext Hex TiUltra | Primary Predicate Device NobelZygoma 45° implants | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | Reusability | Single-use | Single-use | Single-use | Single-use | Single-use | Same as Primary Predicate. | | Shelf-life | 5 years | 5 years | --- | --- | 5 years | Same as Primary Predicate. | | Packaging | Titanium implant sleeve placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid (sterile barrier). The blister is then placed into a carboard box (protective packaging). (single-sterile barrier) (co-packed with preassembled implant mount/implant mount screw) | Titanium implant sleeve casing inside a copolyester vial with a high density polyethylene (HDPE) outer vial cap (1^{st} sterile barrier). The vial is placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lead (2^{nd} sterile barrier), which is then inserted into a cardboard box. (double-sterile barrier) (co-packed with preassembled implant mount/ implant mount screw and with cover screw) | --- | --- | Titanium Implant sleeve placed into a copolyester vial with high density polyethylene (HDPE) outer cap (1^{st} sterile barrier). The vial is placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lead (2^{nd} sterile barrier), which is then inserted into a cardboard box. (double-sterile barrier) | Subject devices present a single- sterile barrier similar to Nobel Biocare N1 Implants (K211109). | | Duration of use | Permanent implantable | Permanent implantable | Permanent implantable | Permanent implantable | Permanent implantable | Same as Primary Predicate. | | Anatomical location | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper and/or lower jaw (maxilla and/or mandible) | Same as Primary Predicate. | Page 9 of 35 {13} N Nobel Biocare™ # 1.7.2 Substantial Equivalence Table - NobelZygoma 0° CC TiUltra Implants | | Subject Device NobelZygoma 0° CC TiUltra | Reference Device #1 NobelZygoma 0° TiUnite | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | 510(k) | K243834 | K161598 | K222497 | K151909 | K202344 | N/A | | Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Southern Implants (Pty) Ltd | Noris Medical | Nobel Biocare AB | N/A | | Representative Image(s) | | | | | | N/A | | Regulatory Aspects | | | | | | | | Product Classification | Class II | Class II | Class II | Class II | Class II | Same as Reference Device #1. | | Regulatory Number / Name | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | 21 CFR 872.3640 Endosseous dental implant | Same as Reference Device #1. | | Primary Product Code | DZE | DZE | DZE | DZE | DZE | Same as Reference Device #1. | | Review Panel | Dental | Dental | Dental | Dental | Dental | Same as Reference Device #1. | | Intended Use and Indications for Use | | | | | | | | Intended Use | NobelZygoma TiUltra implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. | NobelZygoma™ 0° implants are endosseous implants and are integrated in the zygomatic bone (osseointegration). They are intended to be used for anchoring or supporting tooth replacements to restore chewing function. | Functional and esthetic rehabilitation of the edentulous maxilla | Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one- stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary | Nobel Biocare's TiUltra implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. | Same as Reference Device #1. Same as Reference Device #2 and Reference Device #3 with differences in choice of words. | Page 10 of 35 {14} N Nobel Biocare | | Subject Device NobelZygoma 0° CC TiUltra | Reference Device #1 NobelZygoma 0° TiUnite | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | Indications for Use2 | NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | NobelZygoma™ 0° implants are endosseous dental implants indicated to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Straumann Zygomatic implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae. | NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jawbone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early, or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7mm length are for delayed loading only when appropriate stability has been achieved. | Same as Reference #1, Reference Device #2 and Reference Device #3 with differences in choice of words. | | Placement Method | Extra-maxillary | Inside or outside the maxillary sinus | Inside or outside the maxillary sinus | Extra-maxillary | N/A | Same as Reference Device #3 | | Technological Characteristics | | | | | | | | Device Dimensions / Design Specifications | | | | | | | | Implant Length (length as per label) | 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm | 30, 35, 37.5, 40, 42.5, 45, 47.5 and 50mm | ZAGA Round: 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm | 30, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5mm | 7, 8.5, 10, 11.5, 13, 15, 18mm | Same range of lengths as the Reference Device #2. | {15} N Nobel Biocare™ | | Subject Device NobelZygoma 0° CC TiUltra | Reference Device #1 NobelZygoma 0° TiUnite | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | | | | ZAGA Flat: 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60mm | | | | | Implant Diameter | Implant neck: Ø 4.3mm Shaft: Ø 3.9mm Apical thread Diameter: Ø 3.9mm | Implant neck: Ø 4.5mm Shaft: Ø 4.3mm diameter Apical thread Diameter: Ø 4.97mm | ZAGA round: 4.3 mm (coronal) taper to 3.4 mm (apical) ZAFA flat: 4.3 mm (coronal with 3.35 mm flat) taper to 3.4 mm (apical) | 4.2mm (4.2 max diameter body, 3.5 apex) | 3.75, 4.3, 5.0, 5.5mm | Similar to Reference Device #1 and to Primary Predicate device (Section 1.9.1). | | Platform Compatibility | Regular Platform (RP) | Regular Platform (RP) | 4.07mm | 3.75mm (4.2mm neck Ø) | Narrow Platform (NP) Regular Platform (RP) Wide Platform (WP) | Same as Reference Device #1 | | Connection Type | Internal conical Connection (with internal hex) | External Hex Connection | External Hex Connection | Internal conical connection (with internal hex) | Internal conical Connection (with internal hex) | Both the Subject Device and the Reference Device #3 present an internal conical connection (with internal hex). Same connection as Reference Device #7 | | Implant Angulation | (straight) 0° angulation at head of implant | (straight) 0° angulation at head of implant | 55° angulation at head of implant | (straight) 0° angulation at head of implant | (straight) 0° angulation at head of implant | Same as Reference Device #1 | | Angulation compatible Abutments | 45° 60° | 45° 60° | Straight (no angulated or 0°) | 17°, 30°, 45° (extended at 52° and 60° with K210356) | straight (no angulation or 0°) 17° 30° | Same as Reference Device #1 | | Thread Design | Single helix 60° V shape thread form, length 18mm Thread pitch: 0.6mm | Single helix 60° V shape thread form, length 18mm Thread pitch: 0.6mm | Partially threaded root-form implants for placement into the zygoma. Round apex with a thread pitch of 0.8mm | Tapered Screw type (length 13mm) Thread pitch: 1.295 | Double lead thread with groove | Same as Reference Device #1. | | Implant Tip Design | Tapered apex with cut out flutes | Tapered apex with cut out flutes | Tapered with cut out flutes | Double thread, double flutes | Tapered apex with cut out flutes | Same as Reference Device #1. | | Material | Unalloyed titanium grade 4 (ASTM F67) (Implant mount & implant mount screw: titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) according to ASTM F136). | Unalloyed titanium grade grade 4 (ASTM F67) (no implant mount) | Unalloyed titanium grade 4 (ASTM F67), and UTS ≥ 900Mpa (cold-worked) | Titanium alloy Ti 6Al 4V ELI | Unalloyed titanium grade 4 (ASTM F67) | Implant material is the same as Reference Device #1. Implant mount & implant mount screw same materials as the Primary Predicate (see section 1.7.1). | | Surface Treatment | Anodic oxidation (anodization) | Anodic oxidation (anodization) | Grit-blasted | -machined surface at the coronal/shaft region -resorbable blast media (distal Surface/threaded apex) | Anodic oxidation (anodization) | The Subject Device, the Primary Predicate and the Reference Device #1 | Page 12 of 35 {16} N Nobel Biocare™ | | Subject Device NobelZygoma 0° CC TiUltra | Reference Device #1 NobelZygoma 0° TiUnite | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | | | | | | | present an anodic anodized surface. The Subject Device at the collar/shaft present the same Xeal anodized surface as the Level 0 (collar) of the Reference Device #7. The Reference Device #3 presents a machined surface at the collar/shaft. | | **Surface Topography** | TiUltra - two level surface: Level 1 (shaft and coronal part): Xeal yellow anodization - Sa (area roughness) = 0.5±0.3μm - Thickness = 0.17±0.01μm Level 2 (threaded apex): Spark-anodized - Sa = 1.5 ± 0.4μm - Thickness = 12.0±1.2μm | TiUnite – Single level surface: - Sa = 1.2 ± 0.5μm - Thickness = 12.5 ± 2.5 μm | --- | Collar/Shaft (Level 1) - surface roughness total average: - Sa (area roughness) = ca. 0.27μm | TiUltra – Three level surface: Level 0 (collar): Xeal yellow anodization Sa=0.5±0.3μm Thickness = 0.17±0.01μm Level 1 (transition): Spark-anodized - Roughness: Sa=0.8±0.3μm - Thickness: 7.5 ± 0.3μm Level 2 (body/apex): Spark-anodized Sa = 1.5 ± 0.4μm Thickness = 12.0 ± 1.2 μm | The surface roughness of the Subject Device at Level 1 (collar/shaft) is between the surface roughness of the Reference Device #1 and the Reference Device #3. Same Surface technology as Reference Device #7 but featuring two levels instead of three levels. | | **Surface Preservation** | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on apex, shaft, and collar (excl. connection/ platform). Concentration: 0.1-200 μg/cm² | None | None | None | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on apex, shaft, and collar (excl. connection/ platform). Concentration: 0.1-200 μg/cm² | Same soluble salt (protective layer) as Reference Device #7. | Page 13 of 35 {17} N Nobel Biocare™ | | Subject Device NobelZygoma 0° CC TiUltra | Reference Device #1 NobelZygoma 0° TiUnite | Reference Device #2 Zaga Zygomatic system | Reference Device #3 Noris Medical Zygomatic Dental Implant | Reference Device #7 NobelParallel CC TiUltra implants | Comparison | | --- | --- | --- | --- | --- | --- | --- | | Packaging, Sterility, Shelf-Life, Anatomical Location and Use | | | | | | | | Sterile at supply | Yes (Gamma sterilization; SAL 10^{-6}) | Yes (Gamma sterilization; SAL 10^{-6}) | Yes (Gamma sterilization) | Yes (Gamma sterilization) | Yes (Gamma sterilization; SAL 10^{-6}) | Same as Reference Device #1. | | Initial processing needed | No | No | No | No | No | Same as Reference Device #1. | | Reusability | Single-use | Single-use | Single-use | Single-use | Single-use | Same as Reference Device #1. | | Shelf-life | 5 years | 5 years | --- | --- | 5 years | Same as Reference Device #1. | | Packaging | Titanium implant sleeve placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid (sterile barrier). The blister is then placed into a cardboard box (protective packaging). (single-sterile barrier) (co-packed with preassembled implant mount/ implant mount screw) | Titanium implant sleeve with a PEEK sleeve cap placed inside a copolyester vial with a high-density polyethylene (HDPE) outer vial cap (1^{st} sterile barrier). The vial is placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid (2^{nd} sterile barrier), which is then inserted into a cardboard box. (K183069) (double-sterile barrier) (co-packed with cover screw) | --- | --- | Titanium Implant sleeve placed into a copolyester vial with high-density polyethylene (HDPE) vial cap (1^{st} sterile barrier). The vial is placed in a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid (2^{nd} sterile barrier), which is then inserted into a cardboard box. (double-sterile barrier) | Subject Devices present a single-sterile barrier similar to cleared Nobel Biocare N1 Implants (K211109). The differences when compared to Reference Device #1 do not raise different questions of safety and effectiveness. | | Duration of use | Permanent implantable | Permanent implantable | Permanent implantable | Permanent implantable | Permanent implantable | Same as Reference Device #1. | | Anatomical location | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper jaw arch, integrated in the zygomatic bone | Oral cavity - upper and/or lower jaw (maxilla and/or mandible) | Same as Reference Device #1. | Page 14 of 35 {18} N Nobel Biocare™ # 1.7.3 Substantial Equivalence Table – Straight and 17° Multi-unit Abutments (MUAs) Xeal Zygoma and respective Nobel Zygoma Multi-unit Abutment Xeal Zygoma Screws | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | 510(k) | K243834 | K050641 | K052885 | K202344 | N/A | | Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | N/A | | Representative Image(s) | Straight / 0° | Straight / 0° | — | Representative Images of Multi-unit Abutment (MUA) Xeal™ Conical Connection (straight / 0°, 17° and 30°) | N/A | | | 17° | — | 17° | | | | Regulatory Aspects - Multi-Unit Abutments and Screws | | | | | | | Product Classification (MUAs and Screws) | Class II | Class II | Class II | Class II | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Regulatory Number / Name | 21 CFR 872.3630 Endosseous dental implant abutment. | 21 CFR 872.3630 Endosseous dental implant abutment. | 21 CFR 872.3630 Endosseous dental implant abutment. | 21 CFR 872.3630 Endosseous dental implant abutment. | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Primary Product Code | NHA | NHA | NHA | NHA | Same as respective predicate and reference | Page 15 of 35 {19} N Nobel Biocare™ | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | | | | | | devices: Reference Device#4 and Reference Device#5. | | Review Panel | Dental | Dental | Dental | Dental | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Intended Use and Indications for Use - Multi-Unit Abutments | | | | | | | Intended Use³ | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Indications for Use³ | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla or mandible including full arch dentures. | Same as Reference Device#4 and Reference Device#5. | | Intended Use and Indications for Use - Screws | | | | | | | Intended Use³ | Intended for use to fasten dental implant system components to a dental implant or to another component. | Intended for use to fasten dental implant system components to a dental implant or to another component. | Intended for use to fasten dental implant system components to a dental implant or to another component. | N/A | Same as Reference Devices #4 and #5. | Page 16 of 35 {20} N Nobel Biocare | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | Indications for Use³ | The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | N/A | Same as Reference Devices #4 and #5. | | Technological Characteristics Multi-Unit Abutments and Screws | | | | | | | Device Dimensions/ Design Specifications Multi-Unit Abutments and Screws | | | | | | | Abutment Height (A – distance along the axis of the prosthetic screw /gingival height) (B – distance along the axis of the clinical screw) | Straight MUA: A/B: ca. 3, 5, 7, and 9mm 17° MUA: A: ca. 3 and 5mm B: ca. 4 and 6.3mm | A / B: ca. 3mm and 5mm | B: ca. 2mm and 3mm A: ca. 1 and 2mm | Straight MUA: A/B: ca. 1.5, 2.5, 3.5, 4.5mm 17° MUA: A: ca. 1.5 and 2.5mm B: ca. 2.5, 3.5 mm | Similar to respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Multi-unit Abutment width (at the prosthetic platform) | 4.8mm | 4.8mm | 4.8mm | 4.8mm | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Screw Length (total length) | Straight screw: 6.525, 8.525, 10.525, 12.625mm 17° screw: 3.4mm | 6.55mm | 3.4mm | N/A | Similar to Reference Device #4 and same as Reference Device #5. | | Screw Shaft Diameter (Minimum-nominal) | Straight screw: 1.485mm 17° screw: 1.6 mm | 1.485 mm | 1.6mm | N/A | Same as respective predicate and reference devices: Reference | ³ The Intended Use and Indications for Use presented for the Subject NobelZygoma TiUltra Implant system are Device Component (Device Line) specific. The system Indications for Use is given by the Subject Implants. Page 17 of 35 {21} N Nobel Biocare™ | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | | | | | | Device#4 and Reference Device#5. | | Multi-unit Abutment Platform Compatibility | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Narrow Platform (NP) Regular Platform (RP) Wide Platform (WP) | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Multi-unit Abutment Connection Type | External Hex connection | External Hex connection | External Hex connection | Conical Connection | Same as respective predicate and reference devices: Reference Device#4 and Reference Device#5. | | Screws-Screwdriver Interface | Straight screw: MUA driver 17° screw: Unigrip | MUA driver | Unigrip | N/A | Same as respective predicate and reference devices: Reference Device #4 and Reference Device #5. | | Multi-unit Abutment Angulation | straight (0°) 17° angulated (used with compatible 45° Nobel Biocare zygomatic implants) | straight (0°) (used with compatible 45° Nobel Biocare zygomatic implants) | 17° angulated (used with compatible 45° Nobel Biocare zygomatic implants) | Straight (0°) 17° angulated 30° angulated | Same as respective predicate and reference devices: Reference Device #4 and Reference Device #5. | | Multi-unit Abutment and Screw Material | MUAs and Screws: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | MUA: pure titanium according to ASTM F67. Screw: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | MUAs and Screw: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | The Subject Abutments are made of Titanium Alloy, same materials used in Reference Device #5. | | Multi-unit Abutment and Screw Surface Treatment | MUAs: Anodization Screws: partial DLC coated (screw body) | MUA: no treatment (machined) Screws: partial DLC coated (screw body) | MUA: no treatment (machined) Screws: partial DLC coated (screw body) | MUA: Anodization | Same as Reference Device #8. | Page 18 of 35 {22} N Nobel Biocare™ | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | Multi-unit Abutment Surface Topography | Xeal – Single level surface: Sa (area roughness) <0.8 μm | Machined Ra < 3.2 μm | Machined Ra < 3.2 μm | Xeal – Single level surface: Sa (area roughness) <0.8 μm | Same as Reference Device #8. | | Multi-unit Abutment Hydrophilic surface treatment | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on whole abutment surface. Salt concentration: 0.01 – 2.35μg/mm² | None | None | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on whole abutment surface. Salt concentration: 0.01–2.35 μg/mm² | Same soluble salt (protective layer) as Reference Device #8. | | Packaging, Sterility and Shelf-life - Multi-unit Abutments | | | | | | | Multi-unit Abutment Packaging | Polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid forming a single sterile barrier system. co-packed with screws and abutment holder | Polyethylene terephthalate glycol (PETG) blister sealed with a medical Tyvek lid forming a single sterile barrier system) co-packed with screws and abutment holder | Polyethylene terephthalate glycol (PETG) blister sealed with a medical Tyvek lid forming a single sterile barrier system) co-packed with screws and abutment holder | Polyethylene terephthalate glycol (PETG) blister sealed with a medical Tyvek lid forming a single sterile barrier system). | Same as Reference Device #4 and Reference Device #5. | | Multi-unit Abutments Sterility at supply | Yes (Gamma sterilization SAL 10-6) | Yes (Gamma sterilization SAL 10-6) | Yes (Gamma sterilization SAL 10-6) | Yes (Gamma sterilization SAL 10-6) | Same as Reference Device #4 and Reference Device #5. | | Multi-unit Abutments Shelf life | 5 years | 5 years | 5 years | 5 years | Same as Reference Device #4 and Reference Device #5. | | Multi-unit Abutments Initial processing needed | No | No | No | No | Same as Reference Device#4 and Reference Device#5. | Page 19 of 35 {23} N Nobel Biocare™ | | Subject Devices Multi-unit Abutment Xeal Zygoma Ext Hex (Straight and 17°) (Screw: straight and 17° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws) | Reference Device#4 Brånemark System Zygoma Multi-Unit Abutment (Straight) (Screw: Screw for Zygoma MUA) | Reference Device #5 Brånemark System Zygoma Multi-Unit Abutment (17°) (Screw: Brånemark System Zygoma Angled Multi-unit Abutment Screw) | Reference Device #8 Multi-unit Abutment (MUA) Xeal™ Conical Connection | Comparison | | --- | --- | --- | --- | --- | --- | | Packaging, Sterility and Shelf-life – Screws (as standalone) | | | | | | | Screws Packaging | Polyethylene terephthalate glycol (PETG) blister with a Tyvek lid forming a single sterile barrier. | N/A (only available co-packed with MUA) | Polyethylene terephthalate glycol (PETG) blister with a Tyvek lid | N/A | Same as respective Multi-Unit Abutment predicate and reference devices (Reference Device #4 and #5). | | Screws Sterile at supply | Yes (Gamma sterilization SAL 10^{-6}) | N/A (see packaging, sterility, and shelf-life for MUAs) | No (see packaging, sterility, and shelf-life for MUAs) | N/A | Same as respective Multi-Unit Abutment predicate and reference devices (Reference Device #4 and #5). | | Screws Shelf life | 5 years | N/A (see packaging, sterility, and shelf-life for MUAs) | N/A (non-sterile device) (see packaging, sterility, and shelf-life for MUAs) | N/A | Same as respective Multi-Unit Abutment Reference Devices #4 and #5. | | Screws Initial processing needed | No | N/A (see packaging, sterility, and shelf-life for MUAs) | Yes (see packaging, sterility, and shelf-life for MUAs) | N/A | Subject Devices are single-use and provided sterile. No reprocessing submitted as part of this 510(k). | | Anatomical location and Use - Multi-unit Abutments and Screws | | | | | | | Reusability | Single use | Single use | Single use | Single use | Same as Reference Device #4 and Reference Device #5. | | Duration of use | Permanent implantable | Permanent implantable | Permanent implantable | Permanent implantable | Same as Reference Device #4 and Reference Device #5. | | Anatomical location | Oral cavity - upper jaw | Oral cavity - upper jaw | Oral cavity - upper jaw | Oral cavity – upper or lower jaw | Same as Reference Device #4 and Reference Device #5. | Page 20 of 35 {24} N Nobel Biocare™ # 1.7.4 Substantial Equivalence Table - 45° and 60° Multi-unit Abutments (MUAs) Xeal Zygoma and respective 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | | Subject Devices Multi-unit Abutment Xeal Zygoma CC (45° and 60°) Screw: 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | Reference Device #6 Multi-unit Abutment Ext Hex (45° and 60°) Screw: NobelZygoma 0° Angled Multi-Unit Abutment Screw | Reference Device #8 Multi-unit Abutment (MUA) Xeal Conical Connection | Comparison | | --- | --- | --- | --- | --- | | 510(k) | K243834 | K161598 | K202344 | N/A | | Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | N/A | | Representative Image(s) | | | | N/A | | Regulatory Aspects - Multi-Unit Abutments and Screws | | | | | | Product Classification | Class II | Class II | Class II | Same as Reference #6. | | Regulatory Number / Name | 21 CFR 872.3630 Endosseous dental implant abutment | 21 CFR 872.3630 Endosseous dental implant abutment | 21 CFR 872.3630 Endosseous dental implant abutment | Same as Reference #6. | | Primary Product Code | NHA | NHA | NHA | Same as Reference #6. | | Review Panel | Dental | Dental | Dental | Same as Reference #6. | Page 21 of 35 {25} N Nobel Biocare | | Subject Devices Multi-unit Abutment Xeal Zygoma CC (45° and 60°) Screw: 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | Reference Device #6 Multi-unit Abutment Ext Hex (45° and 60°) Screw: NobelZygoma 0° Angled Multi-Unit Abutment Screw | Reference Device #8 Multi-unit Abutment (MUA) Xeal Conical Connection | Comparison | | --- | --- | --- | --- | --- | | Intended Use and Indications for Use - Multi-Unit Abutments | | | | | | Intended Use4 | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis | Same as Reference Device #6. | | Indications for Use5 | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures | Indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla or mandible including full arch dentures. | Same as Reference Device #6. | | Intended Use and Indications for Use - Screws | | | | | | Intended Use4 | Intended for use to fasten dental implant system components to a dental implant or to another component. | Intended for use to fasten dental implant system components to a dental implant or to another component. | N/A | Same as Reference Device #6. | | Indications for Use4 | The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. | N/A | Same as Reference Device #6. | | Technological Characteristics Multi-Unit Abutments and Screws | | | | | | Device Dimensions/ Design Specifications Multi-Unit Abutments and Screws | | | | | | Multi-unit Abutment Height (A - distance along the axis of the prosthetic screw /gingival height) | 45° MUA: A: ca. 3,5,7,9mm B: ca. 5.1, 6.8, 8.2, 9.6mm | 45° MUA: A: ca. 3.7, 6.5, 9.4mm B: ca. 6, 8 and 10mm | A: ca. 1.5 and 2.5mm B: ca. 3.5 and 4.5mm | Within range of Reference Device #6 heights. | {26} N Nobel Biocare™ | | Subject Devices Multi-unit Abutment Xeal Zygoma CC (45° and 60°) Screw: 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | Reference Device #6 Multi-unit Abutment Ext Hex (45° and 60°) Screw: NobelZygoma 0° Angled Multi-Unit Abutment Screw | Reference Device #8 Multi-unit Abutment (MUA) Xeal Conical Connection | Comparison | | --- | --- | --- | --- | --- | | (B – distance along the axis of the clinical screw) | 60° MUA: A: ca. 3,5,7,9mm B: ca. 5.5, 6.5, 7.5, 8.5mm | 60° MUA: A: ca. 4.2 and 8.2mm B: ca. 6 and 8mm | | | | Multi-unit Abutment width (at the prosthetic platform) | 4.8mm | 4.8mm | 4.8mm | Same as Reference Device #6. | | Screw Length (total length) | 8.625 mm | 9.825mm | N/A | Within range of Reference Device #6. | | Screw Shaft Diameter | 1.475 mm | 1.475 mm | N/A | Same as Reference Device #6. | | Multi-unit Abutment Platform Compatibility | Regular Platform (RP) | Regular Platform (RP) | Narrow Platforme (NP) Regular Platform (RP) Wide Platform (WP) | Same as Reference Device #6. | | Multi-unit Abutment Connection Type | Conical Connection (internal hex) | External Hex Connection | Conical Connection (internal hex) | Same as Reference Device #8. | | Screws- Screwdriver Interface | Unigrip | Unigrip | N/A | Same as Reference Device #6. | | Multi-unit Abutment Angulation | 45° and 60° (used with compatible 0° Nobel Biocare zygomatic implants) | 45° and 60° (used with compatible 0° Nobel Biocare zygomatic implants) | straight/no angulation, 17° and 30° angulated | Same as Reference Device #6. | | Multi-unit Abutment and Screw Material | MUAs and Screw: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | MUA and Screw: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | MUA and Screw: Titanium alloy Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium) (ASTM F136) | Same as Reference Device #6. | | Multi-unit Abutment and Screw Surface Treatment | MUA: anodization (Xeal) Screw: partial DLC coated (screw body) | MUA: none Screw: partial DLC coated (screw body) | MUA: anodization (Xeal) Screw: DLC coated | Same as Reference Device #8. | | Multi-unit Abutment Surface Topography | Xeal – Single level surface: Sa (area roughness) <0.8 μm | Ra < 3.2 μm | Xeal – Single level surface: Sa <0.8 μm | Same as Reference Device #8. | Page 23 of 35 {27} N Nobel Biocare | | Subject Devices Multi-unit Abutment Xeal Zygoma CC (45° and 60°) Screw: 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | Reference Device #6 Multi-unit Abutment Ext Hex (45° and 60°) Screw: NobelZygoma 0° Angled Multi-Unit Abutment Screw | Reference Device #8 Multi-unit Abutment (MUA) Xeal Conical Connection | Comparison | | --- | --- | --- | --- | --- | | Multi-unit Abutment Hydrophilic surface treatment | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on whole abutment surface. Salt concentration: 0.01 – 2.35μg/mm² | None | Soluble salt (protective) layer: Sodium dihydrogen phosphate dihydrate and magnesium chloride hexahydrate salt on whole abutment surface. Salt concentration: 0.01– 2.35 μg/mm² | Same soluble salt (protective layer) as Reference Device #8. | | Packaging, Sterility and Shelf-life - Multi-unit Abutments | | | | | | Multi-unit Abutment Packaging | Polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid forming a single sterile barrier system. co-packed with screws and abutment holder | Polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid forming a single sterile barrier system. co-packed with screw | Polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid forming a single sterile barrier system. co-packed with screw and abutment holder | Same as Reference Device #6. | | Multi-unit Abutment Sterile at supply | Yes (Gamma sterilization SAL 10-6) | Yes (Gamma sterilization SAL 10-6) | Yes (Gamma sterilization SAL 10-6) | Same as Reference Device #6. | | Multi-unit Abutment Shelf life | 5 years | 5 years | 5 years | Same as Reference Device #6. | | Multi-unit Abutment Initial processing needed | No | No | No | Same as Reference Device #6. | | Packaging, Sterility and Shelf-life - Screws (standalone) | | | | | | Screw Packaging | Polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek lid forming a single sterile barrier system | Polyethylene terephthalate glycol (PETG) blister with a Tyvek lid | N/A | Same packaging materials as Reference Device #6. | | Screw-Sterile at supply | Yes (Gamma sterilization SAL 10-6) | No (see packaging, sterility, and shelf-life for MUAs) | N/A | Same as Multi-Unit Abutment Reference Device #6. | | Screw Shelf life | 5 years | N/A (see packaging, sterility, and shelf-life for MUAs) | N/A | Same as Multi-Unit Abutment Reference Device #6. | Page 24 of 35 {28} N Nobel Biocare | | Subject Devices Multi-unit Abutment Xeal Zygoma CC (45° and 60°) Screw: 45°/60° NobelZygoma Multi-unit Abutment Xeal Zygoma Screws | Reference Device #6 Multi-unit Abutment Ext Hex (45° and 60°) Screw: NobelZygoma 0° Angled Multi-Unit Abutment Screw | Reference Device #8 Multi-unit Abutment (MUA) Xeal Conical Connection | Comparison | | --- | --- | --- | --- | --- | | Screw Initial processing needed | No | Yes (see packaging, sterility, and shelf-life for MUAs) | N/A | Subject Devices are single-use and provided sterile. No reprocessing submitted as part of this 510(k). | | Anatomical location and Use - Multi-unit Abutments and Screws | | | | | | Reusability | Single-use | Single-use | Single-use | Same as Reference Device #6. | | Duration of use | Permanent implantable | Permanent implantable | Permanent implantable | Same as Reference Device #6. | | Anatomical location | Oral cavity - upper jaw | Oral cavity - upper jaw | Oral cavity – upper or lower jaw | Same as Reference Device #6. | Page 25 of 35 {29} N Nobel Biocare ## 1.7.5 Similarities between the Subject and the Predicate Device(s) ## Subject NobelZygoma TiUltra Implants The similarities between the Subject Device line NobelZygoma TiUltra Implants and the respective Predicate Devices (Primary Predicate, Reference Device #1, Reference Device #2, Reference Device #3 and Reference device #7) are as follows: - The Intended Use of the Subject NobelZygoma TiUltra implants is identical to the Primary Predicate Device and Reference Device #1. - The Indications for Use of the Subject NobelZygoma TiUltra implants are the same to the Primary Predicate Device (NobelZygoma 45° Implants), Reference Device #1 (NobelZygoma 0° Implants), Reference Device #2 (Zaga Zygomatic System) and Reference Device #3 (Noris Medical Zygomatic Implants) but conveyed with differences in choice of words. - The Subject Implants, similar to the Reference Device #3 are intended for extra-maxillary placement. - The Subject and Predicate Devices feature largely identical fundamental design. All Devices are parallel-walled implants with a threaded apex to anchor to the zygomatic bone. - The Subject NobelZygoma TiUltra implants, similar to the Primary Predicate, the Reference Device #1 and the Reference Device #3 have an unthreaded shaft and collar and are available in 0° and/or 45° angulations. The Reference #2 features a 55° angulation at the head of the implant. - The Subject Device, Primary Predicate and Reference Device #1 shared the same thread design, implant tip design and are made of unalloyed titanium grade 4 (per ASTM F67). The surface treatment is anodic oxidation for all these implants. The Reference Device #2 and the Reference Device #3 are also titanium-based implants (unalloyed titanium grade 4 and titanium alloy Ti6Al4V). - The profiles of the Subject Implants are aligned across their entire length up to their respective connection interfaces and have a unified diameter (3.9mm shaft/apex and 4.3mm implant neck). The Subject Implants diameter is almost the same to the Primary Predicate diameter (3.95mm shaft, 3.9mm apex and 4.3mm implant neck). The Reference Device #2 presents a similar implant diameter with 4.3mm at the coronal region for the ZAGA round (or 4.3mm with 3.35 mm flat for the ZAGA flat) and 3.4 mm at the apical region. The Reference Device #3 also has a similar implant diameter (4.2mm neck and 3.5mm apex). Page 26 of 35 {30} N Nobel Biocare - At the collar region all Nobel Biocare implants incorporate a regular platform width (RP). The Subject NobelZygoma 45° Ext Hex TiUltra Implant presents the same Ext Hex connection as the Primary Predicate, while the Subject NobelZygoma 0° CC TiUltra Implant features a Connical Connection similar to the Reference Device #7. - The Subject Devices are pre-assembled and co-packed with an implant mount and implant mount screw similar to the Primary Predicate. - The Subject and all Predicate Devices are single-use implants, provided sterile (gamma sterilization. All Nobel Biocare implants share the same Sterility Assurance Level (SAL 10⁻⁶), have a shelf-life of 5 years, and are sterilized in the same contract sterilizer(s). ## Subject Multi-unit Abutment Xeal Zygoma The similarities between the Subject Device line Multi-unit Abutments Xeal Zygoma and the respective predicate and reference devices (Reference Devices #4, #5, #6 and #8) are as follows: - The Subject Multi-Unit Abutments Xeal Zygoma have the same Intended Use and Indications as the predicate Multi-Unit Abutments (Reference Device #4, #5 and #6). - The fundamental technology and essential geometry of the Subject Multi-unit Abutment Xeal Zygoma External Hex is largely the same as for the existing predicate and reference devices. The Subject Devices have the same angulation (straight and 17°, 45° and 60°), width, platform compatibility (RP) as the respective Reference Device (#4, #5 and #6). - The Subject Devices are made from Titanium alloy (Ti-6Al-4V) same as the Reference Devices #5 and #6. - All devices are provided sterile (gamma irradiation, SAL 10⁻⁶) and are single-use. In addition, for Multi-unit Abutment Xeal Zygoma External Hex (Straight and 17°) - Similarly to the Predicate Devices, the Subject Devices are co-packed with a multi-unit abutment screw and an abutment holder. The abutment holders do not remain in the patient and are made from the same materials as the respective abutment holder predicate and reference devices. - The Subject straight and 17° MUAs, same as the predicate/reference devices, feature an external hexagonal connection and are used with compatible Nobel Biocare 45° zygomatic implants. In addition, for Multi-unit Abutment Xeal Zygoma CC (45° and 60°) - The Subject 45° and 60° MUAs, same as the predicate/reference devices, are used with compatible Nobel Biocare 0° zygomatic implants. ## Subject NobelZygoma Multi-unit Abutment Xeal Zygoma Screws Page 27 of 35 {31} N Nobel Biocare The similarities between the Subject Device line NobelZygoma Multi-unit Abutment Xeal Zygoma Screws and the respective predicate and reference devices (Reference Devices #4, #5 and #6) are as follows: - The Intended Use and Indications for use of the Subject Screws are the same as the respective Reference Devices (#4, #5 and #6). - Like the Predicate/Reference Screws, the Subject Screws are pre-manufactured dental implant screws designed to fasten dental implant system components to a dental implant or to another component. The screw thread engages the internal thread of implant while the screw head engages the seat feature on abutment. Tightening of the screw applies compressive force between the implant and abutment. - All Subject and Predicate/Reference Screws are made from titanium alloy (Ti-6Al-4V) and are partially DLC (Diamond Like Carbon) coated. The Subject Screws feature the same screwdriver interphase as the respective Predicate/Reference Device. - The Subject straight Screws are available in four sizes to fit the varied straight Multi-Unit Abutment heights, plus two single-sized screws for the $45^{\circ} / 60^{\circ}$ Multi-Unit Abutments and the $17^{\circ}$ Multi-Unit Abutments. The Subject Screw length for the $17^{\circ}$ MUAs is the same as the respective Reference Device #5. - All Subject and Predicate/Reference Screws are single-use and available co-packed with the respective Multi-unit Abutments. When co-packed with the respective MUAs, all screws are sterile (gamma irradiation, SAL $10^{-6}$ ) and in the same packaging system with a shelf-life of 5 year. The Subject Screws are also available individually packed (sterile version). Reference Devices #5 and #6 are also available individually packed (non-sterile). # 1.7.6 Differences Between the Subject and Predicate Device(s) ## Subject NobelZygoma TiUltra Implants There are no significant differences between the Subject Device line NobelZygoma TiUltra Implants and the respective Predicate/Reference Devices but there are minor differences as follows: - A different choice of words on the instructions for immediate loading included in the Indications for Use of the Subject NobelZygoma $45^{\circ}$ Ext Hex TiUltra is provided when compared to the Primary Predicate (NobelZygoma $45^{\circ}$ Implants). The indications for use of the Subject Devices includes the zygomatic bone for consistency with the anatomical placement of the device. {32} N Nobel Biocare - The Subject Implants and Reference Device #3 are intended for extra-maxillary applications, whereas the Primary Predicate and Reference Devices #1 and #2 are intended for a broader range of clinical applications, including intra-sinus applications. - While the overall macro-design of the Subject Devices and the respective predicate and reference devices is the same, - the diameter of the Subject NobelZygoma 0° TiUltra is unified with the 45° angulated zygomatic implants and is smaller when compared to the diameter of the Reference Device #1 (NobelZygoma 0° Implants). - the Subject NobelZygoma 0° TiUltra Implant feature a conical connection similar to the Reference Device #3 and the Reference Device #7. - the Subject NobelZygoma 45° Implants introduces a modified implant mount design with an overall slimmer design and a more compact connection interface when compared to the Primary Predicate. In addition, The Subject NobelZygoma 0° CC TiUltra is also provided assembled with a new compatible implant mount and screw. - The Subject Devices are available in implant lengths of up to 60 mm, similar to Reference Device #2. These modifications do not raise different questions of safety and effectiveness. The implant length range of the Subject Devices (from 30mm to 60mm) is the same as that of the Reference Device #2. The additional lengths and modified features were tested whenever deemed to represent a worst-case. Worst-case fatigue testing was conducted to demonstrate that the Subject Device performs at least as well as the defined benchmark reference system and that the difference does not raise different questions of safety and effectiveness. - The Subject Implants introduce a modified surface topography (TiUltra) with a soluble salt (protective) layer as surface preservation. This TiUltra surface technology, consisting of a multi-level surface topography and including a soluble salt (protective) layer, is already applied to existing Nobel Biocare TiUltra dental implants (e.g., Reference Device #7). - Comparison with Reference Device #7: The Subject Devices have a two-level surface topography, compared to the three-level topography of Reference Device #7 (different intended use and indications). The surface roughness of the two-level design falls within the roughness range of the three-level surface. The soluble salt (protective) layer in the Subject Devices is identical in composition and concentration to that of Reference Device #7. - Comparison with Reference Device #3: {33} N Nobel Biocare Both zygomatic implants are unthreaded at the shaft/collar area (Level 1). The Subject Devices exhibit a rougher surface at Level 1, as demonstrated by comparative verification testing. - Surface Treatment Comparison: The Subject Devices, along with the Primary Predicate, Reference Device #1 and Reference Device #7 are anodized. In contrast, Reference Device #3 features a machined surface at the coronal/shaft region and a resorbable blast media surface treatment at the distal region. The TiUltra surface of the Subject Devices does not raise new questions regarding substantial equivalence. This is supported by comparative roughness verification testing with Reference Device #3. Real-world evidence (RWE) on the Subject Devices, along with clinical data comparing NobelReplace CC PMC (machined collar) and NobelReplace CC TiUnite (anodized collar), as well as clinical data on the Nobel Biocare TiUltra implant family, support the surface treatment of the Subject Devices at Level 1. This is further supported by worst-case fatigue testing, biocompatibility evaluation, and sterility and packaging performance. - The Subject Devices present a single-sterile barrier packaging configuration similar to Nobel Biocare N1 TiUltra Implants (K211109). # Multi-unit Abutments Xeal Zygoma There are no significant differences between the Subject Device line Multi-unit Abutments Xeal Zygoma and the respective Predicate/Reference Devices but ther…
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