Neodent Implant System - Zirconia Implant System

K250271 · JJGC Indústria e Comércio de Materiais Dentários S.A. · DZE · Aug 18, 2025 · Dental

Device Facts

Record IDK250271
Device NameNeodent Implant System - Zirconia Implant System
ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Product CodeDZE · Dental
Decision DateAug 18, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks. The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

Device Story

Neodent Implant System - Zirconia Implant System expands existing portfolio with new zirconia implants and abutments. Implants (Y-TZP) placed in maxilla/mandible to support prosthetic restorations; available in Bone Level (BL) and Tissue Level (TL) configurations. System includes cover screws, healing abutments (PEEK), provisional copings (PC), and various zirconia bases (Universal, Bridge, C) for custom prosthetic support. Components feature internal 'ZiLock' connection. Used by dental clinicians in clinical settings. Workflow involves surgical placement; prosthetic design via CAD/CAM software (Dental Wings, Exocad, 3Shape, or Sirona); and manufacturing at Straumann or Sirona validated milling centers. Output is a customized dental restoration. Benefits include restored chewing function and esthetic rehabilitation. Device is provided sterile (EO) or requires end-user moist heat sterilization.

Clinical Evidence

Bench testing only. Includes dynamic fatigue testing (ISO 14801), torsion strength, insertion torque, and pull-out tests. Biocompatibility assessed per ISO 10993-1, -5, and -18. Software validation performed for Sirona Digital Workflow. Clinical literature review supported the safety of short implants (<7mm) by comparing titanium and zirconia implant osseointegration outcomes (BIC%, fBIC, BATA).

Technological Characteristics

Materials: Yttrium-stabilized zirconium dioxide (Y-TZP), PEEK, Polycarbonate, Titanium alloy (ASTM F136). Connection: Internal indexing (Zilock). Sterilization: Ethylene Oxide (SAL 1x10⁻⁶) or end-user moist heat. Workflow: CAD/CAM (Sirona/Straumann validated milling). Dimensions: Implants 5.0mm diameter; lengths 5-13mm. Software: Sirona inLab/CEREC workflow for Zirconia Base C.

Indications for Use

Indicated for patients requiring dental implants in the maxilla or mandible to support prosthetic devices (artificial teeth) for chewing function restoration. Applicable for single or multiple unit restorations, immediate or conventional loading, and single or two-stage surgical procedures. Contraindicated for immediate loading if primary stability <35 N.cm or lack of physiological occlusion. Short implants (5mm) restricted to two-stage procedures.

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 JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Sr. Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 August 18, 2025 Re: K250271 Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, PNP Dated: July 15, 2025 Received: July 15, 2025 Dear Jennifer Jackson: 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} K250271 - Jennifer Jackson 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} K250271 - Jennifer Jackson 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, Andrew I. Steen -S 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) **K250271** **Device Name** Neodent Implant System - Zirconia Implant System **Indications for Use (Describe)** **Zirconia Implants:** The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks. **Zi Transmucosal Cover Screw and Healing:** The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. **Zi Transmucosal Provisional Coping:** The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. **Zi Transmucosal Abutment Replacement Screw:** The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. **Zi Transmucosal Universal Base:** The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. **Zirconia Base for Bridge:** The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the {4} Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. Zirconia Base C: The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. 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." {5} K250271 # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary # 510(k) Summary # Submitter's Contact Information Submitter: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810, USA Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: JJGC Indústria e Comércio de Materiais Dentários S.A (dba Neodent) Av. Juscelino Kubitschek de Oliveira, 3291 Curitiba, Paraná, Brazil 81270-200 Registration No.: 3008261720 Owner/Operator No.: 10031702 Contact Person: Jennifer M. Jackson, MS, RAC Sr. Director, Regulatory Affairs and Quality Phone Number: +1 978 747-2509 Fax Number: +1 978 747-0023 Prepared By &amp; Leticia Milani Alternate Contact: Regulatory Affairs Analyst JJGC Indústria e Comércio de Materiais Dentários SA E-mail: leticia.milani@neodent.com Date Prepared: August 18, 2025 # Name of the Device Trade Names: Neodent Implant System - Zirconia Implant System Common Name: Endosseous dental implant Classification Name: Endosseous dental implant Regulation Number: 21 CFR 872.3640 Device Classification: II Primary Product Code(s): DZE JJGC Indústria e Comércio de Materiais Dentários S.A. {6} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary Secondary Product Code(s): NHA, PNP Classification Panel: Dental Products ## Predicate Device(s) ### Primary Predicate: K201491 Neodent Implant System – Zirconia Implant System ### Reference Devices: K210336 Neodent Implant System – Zirconia Implant System K231803 Neodent Implant System – Zirconia Implant System K101945 Neodent Implant System K160964 Neodent Implant System – Titanium Bases for CEREC K163194 Neodent Implant System – GM Line K192229 Neodent Implant System – GM Titanium Base for Bridge K123022 Neodent Implant System K202942 Straumann® 4 mm Short Implants K182620 MRI Compatibility for Existing Neodent Implant System ## Device Description This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers. The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm. The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm. JJGC Indústria e Comércio de Materiais Dentários S.A. {7} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration. The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant. The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of $4\mathrm{mm}$ and is available with gingival heights of 0.3, 1.0 and $1.5\mathrm{mm}$ . The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions: | Material | Associated Material 510(k) | Minimum wall thickness | Maximum angulation | | --- | --- | --- | --- | | IPS e.max CAD HT | K132209 | 0.9 mm | 30° | | IPS e.max CAD LT | K132209 | 0.9 mm | | | N!ce | K171773 | 1.0 mm | | | IVOCLAR Multilink cement | K130436 | N/A | | | Zirconia N!ce® LT | K222836 | 0.4 mm | | | Zirconia N!ce® HT | K222836 | 0.4 mm | | | Zirconia N!ce® XT | K222836 | 0.4 mm | | | PMMA N!ce | K071548 | 0.7 mm | | | Panavia—Kuraray Cement | K150704 | N/A | N/A | The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of $4\mathrm{mm}$ and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions: JJGC Industria e Comércio de Materials Dentários S.A. {8} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary | Material | Associated Material 510(k) | Minimum wall thickness | Maximum angulation | | --- | --- | --- | --- | | Zirconia N!ce® LT | K222836 | 0.4 mm | 30° | | Zirconia N!ce® HT | K222836 | 0.4 mm | | | Zirconia N!ce® XT | K222836 | 0.4 mm | | | PMMA N!ce | K071548 | 0.7 mm | | | Panavia—Kuraray Cement | K150704 | N/A | N/A | The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions: | Material | Associated Material 510(k) | Minimum wall thickness | Maximum angulation | | --- | --- | --- | --- | | IPS e.max CAD | K132209 | 0.9 mm | 20° | | IVOCLAR Multilink cement | K130436 | N/A | N/A | All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization. Intended Use Zirconia Implants: The Zirconia Implants are indicated for surgical intraoral installation in bone with density I / II or in bone III / IV, according to Lekholm &amp; Zarb's bone classification (1985), in the maxilla or mandible. It may be used as a support for single-unit or multiple-unit prosthesis in immediate or conventional loading protocol. It may be installed immediately after the extraction of dental root. For the purposes of immediate loading, primary stability must reach, at least, 35 N.cm and the patient must present physiological occlusion. JJGC Indústria e Comércio de Materiais Dentários S.A. {9} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary Zi Transmucosal Cover Screw and Healing: The Zirconia Cover Screw is intended for use during the osseointegration phase of Zirconia Implant 5.0, which will be rehabilitated using the delayed loading technique. It should remain submucosal, preventing tissue growth over the implant platform. The Zirconia Healing is used to maintain soft tissues during the osseointegration phase of Zirconia Implant 5.0, which will be rehabilitated using the delayed loading technique. It can be used during the implant installation surgery or during the reopening surgery (second surgical phase). It should be selected based on the available interocclusal space, the height of the transmucosal component, and the three-dimensional position of the implant. Both abutments are only available for Neodent Zirconia Implant System, being compatible with implants of the same line. Zi Transmucosal Provisional Coping: The Zi Transmucosal Provisional Coping has double function. It can be used for: molding procedure, identifying the three-dimensional position of the prosthetic abutment installed in the mouth; and, after customization, use as a Provisional Coping in the production of a provisional prosthesis cemented over the corresponding abutment from Neodent Zirconia Implant System. The abutment is only available for Zirconia Implant System, being compatible with implants of the same line. Zi Transmucosal Abutment Replacement Screw: The Zi Transmucosal Abutment Replacement Screw is indicated to fix the abutment to the implant. Zi Transmucosal Universal Base: The Zi Transmucosal Universal Base is indicated according to the interocclusal space available, existing gingival height and three-dimensional position of the implant. This product can be used in single-unit restorations. This product is compatible only with the Neodent Zirconia Implant System. All digitally designed restorations to be used with the Zi Transmucosal Universal Base devices are intended to be sent to Straumann for manufacture at a validated milling center. Zirconia Base for Bridge: The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed restorations to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. JJGC Indústria e Comércio de Materiais Dentários S.A. {10} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary Zirconia Base C: The Zirconia Base C is indicated according to the interocclusal space available, existing gingival height and three-dimensional position of the implant. This product must be used in single-unit restorations. This product is compatible only with the Neodent Zirconia Implant System. This product must be used following the CAD/CAM technique through the Sirona Dental CAD/CAM System. ## 1.1 Indications for Use Zirconia Implants: The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks. Zi Transmucosal Cover Screw and Healing: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. Zi Transmucosal Provisional Coping: The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Zi Transmucosal Abutment Replacement Screw: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may JJGC Indústria e Comércio de Materiais Dentários S.A. {11} JJGC Indústria e Comércio de Materiais Dentários S.A. # Traditional 510(k) Submission ## Neodent Implant System - Zirconia Implant System 510(k) Summary be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. ## Zi Transmucosal Universal Base: The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. ## Zirconia Base for Bridge: The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. ## Zirconia Base C: The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. {12} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables: Table 42 – Table of Substantial Equivalence for Zirconia Implants | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | | | --- | --- | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K210336 Neodent Implant System – Zirconia Implant System | K123022 Neodent Implant System | K202942 Straumann® 4 mm Short Implants | | Indications for Use | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Titamax WS implant is indicated for a delayed loading protocol. The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures. | Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for: • Fixed partial dentures/splinted units (one implant per unit) • Pontic cases in combination with at least one longer implant • Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants | | Material | Yttrium-stabilized zirconium dioxide (Y-TZP). | Yttrium-stabilized zirconium dioxide (Y-TZP). | Yttrium-stabilized zirconium dioxide (Y-TZP). | | | | Implant-Abutment interface | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | | | | Design | Cylindrical body geometry Apically tapered format Trapezoidal threads profile Bone level | Tapered body geometry Apically tapered format Trapezoidal threads profile Bone level | Tapered body geometry Apically tapered format Trapezoidal threads profile Bone level | Bone level | Tissue level | | Diameter (Ø) | 5.0 mm | 4.3 mm | 3.75 mm | 4.0, 5.0 and 6.0 mm | 4.1 and 4.8 mm | JJGC Indústria e Comércio de Materiais Dentários S.A. {13} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | | | --- | --- | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K210336 Neodent Implant System – Zirconia Implant System | K123022 Neodent Implant System | K202942 Straumann® 4 mm Short Implants | | Length | 5; 8; 10; 11.5 and 13 mm | 8; 10; 11.5 and 13 mm | 10; 11.5 and 13 mm | 5 and 6 mm | 4.0 mm | | Tissue level implant collar length | 1.8 mm | | | | 1.8 mm | | Single use | Yes | Yes | Yes | Yes | Yes | | Sterilization Method | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | JJGC Indústria e Comércio de Materiais Dentários S.A. {14} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary Table 43 – Table of Substantial Equivalence for Zirconia Cover Screw and Healing Abutment | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K231803 Neodent Implant System – Zirconia Implant System | | Indications for Use | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. | The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion. | | Material | PEEK Dental Grade | Cover Screw: Titanium alloy, according to ASTM F136. Healing: Yttrium-stabilized zirconium dioxide (Y-TZP) | PEEK Dental Grade | | Implant-Abutment Connection | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | | Overall dimensions | Diameter: 5.5 mm Gingival height: 2.0 and 3.5 mm | Diameter: 3.75 and 4.5 mm Gingival height: 1.5 and 2.5 mm | | | Single Use | Yes | Yes | Yes | | Sterilization Method | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | Provided sterile via Ethylene Oxide to a SAL of 1x10⁻⁶. | JJGC Indústria e Comércio de Materiais Dentários S.A. {15} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary Table 44 – Table of Substantial Equivalence for Zi Transmucosal Universal Base and Screw | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | | --- | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K231803 Neodent Implant System – Zirconia Implant System | K223638 Neodent Implant System – Helix Short Implant System | | Indications for Use | The Zi Universal Transmucosal Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center | The Helix Short Implant Titanium Base is a titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center. | | Material | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium Alloy ASTM F136. | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium Alloy ASTM F136. | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium Alloy ASTM F136. | | | Implant-Abutment Connection | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | | | Diameter | Ø 5.5 mm | Ø 3.75 and 4.5 mm | Ø 3.75 and 4.5 mm | | | Gingival Height | 0.3, 1.0 and 3.5 mm | 1.5 and 2.5 mm | 3.5 and 4.5 mm | 0.2; 1.5, 2.5 and 3.5 mm | | Maximum Angulation of Prosthetic Structure | 30° | 30° | 30° | | | Design Workflow | Zi Universal Base library on Dental Wings, Exocad and 3Shape softwares. | Zirconia Base library on Dental Wings, Exocad and 3Shape softwares. | Zirconia Base library on Dental Wings, Exocad and 3Shape softwares. | | JJGC Indústria e Comércio de Materiais Dentários S.A. {16} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | | PRIMARY PREDICATE DEVICE | | REFERENCE PREDICATE DEVICE | | | | --- | --- | --- | --- | --- | --- | --- | --- | | K Number | K250271 | | K201491 Neodent Implant System – Zirconia Implant System | | K231803 Neodent Implant System – Zirconia Implant System | | K223638 Neodent Implant System – Helix Short Implant System | | Manufacturing Workflow | Straumann Milling Center | | Straumann Milling Center | | Straumann Milling Center | | | | Top Half Material | Material | Minimum thickness | Material | Minimum Thickness | Material | Minimum Thickness | | | | IPS e.max CAD HT | 0.9 mm | IPS e.max CAD LT | 0.9 mm | IPS e.max CAD LT | 0.9 mm | | | | IPS e.max CAD LT | 0.9 mm | IPS e.max CAD Press | 0.9 mm | IPS e.max CAD Press | 0.9 mm | | | | Zirconia N!ce® LT | 0.4 mm | Zirconia N!ce LT | 0.4 mm | Zirconia N!ce LT | 0.4 mm | | | | Zirconia N!ce® HT | 0.4 mm | Zirconia N!ce HT | 0.4 mm | Zirconia N!ce HT | 0.4 mm | | | | Zirconia N!ce® XT | 0.4 mm | Zirconia N!ce XT | 0.4 mm | Zirconia N!ce XT | 0.4 mm | | | | PMMA N!ce | 0.7 mm | PMMA N!ce | 0.7 mm | PMMA N!ce | 0.7 mm | | | | N!ce | 1.0 mm | N!ce | 1.0 mm | N!ce | 1.0 mm | | | | *PMMA N!ce is indicated to remain in the mouth only for up to 180 days | | *PMMA N!ce is indicated to remain in the mouth only for up to 180 days **PMMA N!ce is the new description for Polycon ae. | | *PMMA N!ce is indicated to remain in the mouth only for up to 180 days **PMMA N!ce is the new description for Polycon ae. | | | | Minimum Abutment Post-height | 4 mm | | 4 mm | | 4 mm | | 4.0 – 6.0mm | | Single Use | Yes | | Yes | | Yes | | | | Sterilization Method | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | | | JJGC Indústria e Comércio de Materiais Dentários S.A. {17} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary Table 45 – Table of Substantial Equivalence for Zirconia Base for Bridge | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K192229 Neodent Implant System – GM Titanium Base for Bridge | | Indications for Use | The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed restorations to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations. | | Material | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium alloy ASTM F136. | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium Alloy ASTM F136. | | | Implant-Abutment Connection | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | | | Diameter | Ø 4.5 mm | Ø 3.75 and 4.5 mm | | | Gingival Height | 1.5, 2.5 and 3.5 mm | 1.5 and 2.5 mm | | | Maximum Angulation of Prosthetic Structure | 30° | 30° | | | Design Workflow | Zi Universal Base library on Dental Wings, Exocad and 3Shape softwares. | Zirconia Base library on Dental Wings, Exocad and 3Shape softwares. | | | Manufacturing Workflow | Straumann Milling Center | Straumann Milling Center | | JJGC Indústria e Comércio de Materiais Dentários S.A. {18} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | | PRIMARY PREDICATE DEVICE | | REFERENCE PREDICATE DEVICE | | --- | --- | --- | --- | --- | --- | | K Number | K250271 | | K201491 Neodent Implant System – Zirconia Implant System | | K192229 Neodent Implant System – GM Titanium Base for Bridge | | Top Half Material | Material | Minimum thickness | Material | Minimum Thickness | | | | Zirconia N!ce® LT | 0.4 mm | IPS e.max CAD LT | 0.9 mm | | | | Zirconia N!ce® HT | 0.4 mm | IPS e.max CAD Press | 0.9 mm | | | | Zirconia N!ce® XT | 0.4 mm | Zirconia N!ce LT | 0.4 mm | | | | PMMA N!ce | 0.7 mm | Zirconia N!ce HT | 0.4 mm | | | | *PMMA N!ce is indicated to remain in the mouth only for up to 180 days | Zirconia N!ce XT | 0.4 mm | | | | | | | PMMA N!ce | 0.7 mm | | | | | | N!ce | 1.0 mm | | | | | | *PMMA N!ce is indicated to remain in the mouth only for up to 180 days **PMMA N!ce is the new description for Polycon ae. | | | | Single Use | Yes | | Yes | | | | Sterilization Method | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10-6 | | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10-6 | | | JJGC Indústria e Comércio de Materiais Dentários S.A. {19} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary Table 46 – Table of Substantial Equivalence Zirconia Base C | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | | --- | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K231803 Neodent Implant System – Zirconia Implant System | K160964 Neodent Implant System – Titanium Bases for CEREC | | Indications for Use | The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. | The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center | The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | | Material | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium alloy ASTM F136. | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium alloy ASTM F136. | Base: Yttrium-stabilized zirconium dioxide (Y-TZP). Screw: Titanium alloy ASTM F136. | | | Implant-Abutment Connection | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | Straight internal connection indexing features (Zilock) | | | Gingival height | 1.5, 2.5, 3.5 and 4.5 mm | 1.5 and 2.5 mm | 3.5 and 4.5 mm | 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm | | Maximum Angulation of Prosthetic Structure | 20° | 30° | 30° | 20° | | Design Workflow | Zirconia Base C library on Sirona CEREC Software. | Zirconia Base library on Dental Wings, Exocad and 3Shape softwares. | Zirconia Base library on Dental Wings, Exocad and 3Shape softwares. | Titanium Base C library on Sirona CEREC Software. | | Manufacturing Workflow | Sirona InLab Milling Unit | Straumann Milling Center | Straumann Milling Center | Sirona InLab Milling Unit | JJGC Indústria e Comércio de Materiais Dentários S.A. {20} # Traditional 510(k) Submission # Neodent Implant System - Zirconia Implant System 510(k) Summary | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | | --- | --- | --- | --- | | K Number | K250271 | K201491 Neodent Implant System – Zirconia Implant System | K231803 Neodent Implant System – Zirconia Implant System | K160964 Neodent Implant System – Titanium Bases for CEREC | | Top Half Material | Material | Minimum Thickness | | Material | Minimum Thickness | | Material | Minimum Thickness | | Material | Minimum Thickness | | IPS e.max CAD | 0.9 mm | | IPS e.max CAD LT | 0.9 mm | | IPS e.max CAD PT | 0.9 mm | | IPS e.max CAD | 0.9 mm | | | IPS e.max CAD Press | 0.9 mm | | IPS e.max CAD Press | 0.9 mm | | | | Zirconia Nfce LT | 0.4 mm | | Zirconia Nfce LT | 0.4 mm | | | | Zirconia Nfce HT | 0.4 mm | | Zirconia Nfce HT | 0.4 mm | | | | Zirconia Nfce XT | 0.4 mm | | Zirconia Nfce XT | 0.4 mm | | | | PMMA Nfce | 0.7 mm | | PMMA Nfce | 0.7 mm | | | | Nfce | 1.0 mm | | Nfce | 1.0 mm | | | *PMMA Nfce is used for provisional prosthetic restorations. **PMMA Nfce is the new description for Polycon ae. | | *PMMA Nfce is used for provisional prosthetic restorations. **PMMA Nfce is the new description for Polycon ae. | | | Minimum Abutment Post-height | 4.7 mm | 4 mm | 4 mm | 4.7 mm | | Single Use | Yes | Yes | Yes | | | Sterilization Method | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | Provided sterile via Ethylene Oxide and end-user Moist Heat sterilized to a SAL of 1x10⁻⁶ | | JJGC Indústria e Comércio de Materiais Dentários S.A. {21} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary # Performance Testing ## Bench Testing Assessments regarding dynamic fatigue testing were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants". For dynamic fatigue tests, the results demonstrated that in identical conditions, the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices. Torsion tests were also performed to evaluate the strength of the screw used to fix all subject abutments against maximum twisting forces. The results prove that there is an adequate torsion strength in accordance with the installation torque recommended in IFU. Insertion tests were performed to evaluate the insertion torque of the Zirconia Implant System when inserted into sawbones material representing bone type I, II, III and IV. The Implant Surface Area simulation and Pull Out Test were also made to evaluate and represent the clinical use of the Zi Transmucosal Implant less than 7mm of length. In regular condition, although the results demonstrate that the subject devices have a greater surface area when compared to the reference devices. Pull Out Test results support the surface evaluation with higher resistance values for the subject devices. Referenced K210336 and K201491 for the surface analyses for wear or other damage, including microscopic and SEM images, of the internal thread area of the ceramic implant body and mated ceramic two-piece abutment via titanium abutment fixation screw, following cyclic fatigue loading per recommended ISO 14801. Referenced K201491 for surface treatment and cleaning procedure and XPS (X-ray photoelectron spectroscopy). All subject devices are manufactured from the same Zirconia raw material, equipment, processes and parameters and receive the same surface treatment as the reference devices. JJGC Indústria e Comércio de Materiais Dentários S.A. {22} JJGC Indústria e Comércio de Materiais Dentários S.A. # Traditional 510(k) Submission ## Neodent Implant System - Zirconia Implant System 510(k) Summary ## Software Validation A study to demonstrate the software validation of Sirona Digital Workflow applicable to Zirconia Bases C were performed. The analysis was based on the compatibility with the blocks available in Sirona Software, as well as in the verification that critical design parameters - such as minimum wall thickness and maximum angulation - are respected and properly monitored by the system. The results show that the accuracy requirement was met using the Sirona Digital Workflow. ## MRI Compatibility Testing An assessment was made to demonstrate that the MR conditional labeling from K182620 is applicable to the subject devices, and a patient treated with them can be safely scanned observing the parameters previously established per reference devices. ## Biocompatibility Testing Biological assessments were performed according to ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” and to the FDA Guidance document “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’, Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016” for each subject device. Representative samples of the subject devices were subjected to the following: - Biological Safety Assessment guided by ISO 10993-1. - Chemical characterization was performed per ISO 10993-18. - Cytotoxicity testing was performed per ISO 10993-5. The subject devices are equivalent in material and manufacturing processes to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised and no additional biocompatibility testing was required. {23} Traditional 510(k) Submission Neodent Implant System - Zirconia Implant System 510(k) Summary # Sterilization validation For the proposed devices supplied sterile via Ethylene Oxide (EO), the method was validated to a sterility assurance level (SAL) of 1×10⁻⁶ in accordance with ISO 11135:2014, "Ethylene Oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices". EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals". For proposed devices that must be sterilized before installation in the mouth, the steam sterilization method was validated according to ISO 17665 – 1 "Sterilization of Health Care Products – Moist Heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", using the parameters described in IFU. The sterilization of the subject device are identical to the sterilization already cleared for the primary and reference predicate devices. The Subject devices are not represented to be "pyrogen free". The endotoxin test and validation are performed in JJGC, in microbiology laboratory, in accordance with the standard ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing, ISO 11737-3 – Sterilization of health care products — Microbiological methods – Bacterial endotoxin testing and with US Pharmacopeia chapter 85 – Bacterial Endotoxins Test. The test method aims at the determination of bacterial endotoxins in implant devices supplied sterile using the turbidimetric kinetic method. The obtained results were &lt;0.05 EU/device. # Shelf Life The expiration date of the devices was determined considering the integrity of the product and the packaging tests after shelf-life testing. The packaging of the proposed devices is identical to the packaging of the primary predicate and reference devices. The Shelf Life for Zirconia Devices is 5 years. # Clinical Literature Clinical literature review was conducted to support the safety of Zi Transmucosal Implant less than 7mm of length. The animal studies demonstrated that Titanium and Zirconia implants yielded very similar BIC% results after a comparable healing period. Consequently, both implants are JJGC Indústria e Comércio de Materiais Dentários S.A. {24} JJGC Indústria e Comércio de Materiais Dentários S.A. # Traditional 510(k) Submission ## Neodent Implant System - Zirconia Implant System 510(k) Summary expected to achieve similar osseointegration outcomes and can be compared to demonstrate clinical behavior. Additionally, histomorphometry evaluation and secondary parameters, such as the first bone-to-implant contact (fBIC) and the bone area to total area (BATA) ratio, also reinforced the ability of zirconia implants to promote bone formation around them in a manner equivalent to titanium implants. Thus, Zirconia Implants lower than 7mm of length represent a reliable alternative for rehabilitating edentulous patients, when used according to the IFU orientations. ## Conclusion The subject devices and the primary predicate device have similar indications for use, intended use, design, raw material and overall dimensions. Thus, all documentation submitted in this premarket notification demonstrate that the proposed devices are substantially equivalent to the primary predicate and reference devices.
Innolitics
510(k) Summary
Decision Summary
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