Atlantis® Abutments in Titanium

K250081 · Dentsply Sirona · NHA · Apr 11, 2025 · Dental

Device Facts

Record IDK250081
Device NameAtlantis® Abutments in Titanium
ApplicantDentsply Sirona
Product CodeNHA · Dental
Decision DateApr 11, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Device Story

Patient-specific dental abutments (Atlantis Abutment, Crown, Conus, Healing) connect endosseous implants to prosthetic restorations; fabricated via CAD/CAM based on patient dental models; clinician prescribes design; Dentsply Sirona manufactures internally or via 3Shape Abutment Designer Software (K151455) using locked design libraries. Features include Angulated Screw Access (ASA) for lingual access; titanium or gold-shaded titanium (PVD-applied TiN). Used in dental clinics by clinicians to restore chewing function. Output is a customized abutment; clinical decision-making relies on patient anatomy and implant compatibility. Benefits include aesthetic outcomes and functional restoration. Updated to MR Conditional status.

Clinical Evidence

No clinical data. Bench testing only: MR safety (ASTM F2052, F2213, F2119, F2503), biocompatibility (ISO 10993-1, 10993-5), reprocessing/sterilization validation (ISO 17665, 14937), and CAD/CAM software validation. Fatigue testing from original clearances remains valid.

Technological Characteristics

Materials: Titanium alloy, Gold-shaded Titanium (PVD TiN). Connection: Internal Conical, Internal Hex, External Hex. Dimensions: Patient-specific, max 15mm height. Connectivity: CAD/CAM workflow (internal VAD or 3Shape). Sterilization: Moist heat. Software: Locked design library.

Indications for Use

Indicated for partially or completely edentulous patients requiring prosthetic support via endosseous dental implants in the mandible or maxilla. Includes single/multiple tooth prostheses, removable attachment-retained prostheses, and temporary soft tissue healing abutments.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 11, 2025 Dentsply Sirona Laura Sorbin Sr. Technical RA Manager 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401 Re: K250081 Trade/Device Name: Atlantis® Abutments in Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 8, 2025 Received: January 13, 2025 Dear Laura Sorbin: 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 & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250081 - Laura Sorbin 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} K250081 - Laura Sorbin 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 Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K250081 Device Name Atlantis® Abutments in Titanium Indications for Use (Describe) Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 3.0 (Yellow), 3.5, 4.0 (Aqua), 4.5, 5.0 (Lilac), 4.0 (Blue - Previous) Abutment Platform Diameter (in mm): 2.330 (Yellow), 2.866 (Aqua), 3.865 (Lilac), 3.368 (Blue - Previous) Implant Manufacturer: MIS Implant Technologies Inc. Implant System: V3 (NP, SP), C1 (NP, SP, WP) Implant Diameter (in mm): V3: 3.30 (NP), 3.90, 4.3, 5.0 (SP); C1: 3.30 (NP), 3.75, 4.2 (SP), 5.0 (WP) Abutment Platform Diameter (in mm): V3: 2.765 (NP), 3.16 (SP); C1: 2.76 (NP), 3.16 (SP), 4.01 (WP) Implant Manufacturer: Altatec GmbH Implant System: Conelog Screw-Line Implant Implant Diameter (in mm): 3.3, 3.8, 4.3, 5.0 Abutment Platform Diameter (in mm): 2.80 (3.3), 3.00 (3.8, 4.3), 3.80 (5.0) Implant Manufacturer: Nobel Biocare Implant System: NobelActive Implant Diameter (in mm): 3.0 Abutment Platform Diameter (in mm): 2.461 Implant System: Branemark System (NP, RP, WP) Implant Diameter (in mm): 3.3 (NP), 3.75, 4.0 (RP), 5.0, 5.5 (WP) FORM FDA 3881 (6/20) Page 1 of 2 PSC Publishing Services (301) 443-6740 {4} Abutment Platform Diameter (in mm): 3.476 (NP), 4.069 (RP), 5.033 (WP) Implant Manufacturer: BioHorizons Implant System: Prodigy System Internal/Tapered Internal Implant Diameter (in mm): 3.5, 4.5, 5.7 Abutment Platform Diameter (in mm): 3.434 (3.5), 4.399 (4.5), 5.644 (5.7) Implant System: Maestro Implant Diameter (in mm): 3.5, 4.0, 5.0 Abutment Platform Diameter (in mm): 3.708 (3.5), 4.242 (4.0), 5.258 (5.0) Implant Manufacturer: Biomet 3i Implant System: Certain, Certain Prevail, Certain XP Implant Diameter (in mm): Certain: 3.25, 4, 5, 6; Certain Prevail: 3.4, 4, 5; Certain XP: 5, 6 Abutment Platform Diameter (in mm): 3.404 (3.25, 3.4), 4.012 (4), 4.942 (5), 5.951 (6) Implant System: Osseotite Tapered and Osseotite Parallel Walled Implant Diameter (in mm): 3.25, 3.75, 4.0, 5.0, 6.0 Abutment Platform Diameter (in mm): 4.056 (3.25, 3.75, 4.0), 4.978 (5.0), 5.985 (6.0) 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." FORM FDA 3881 (6/20) {5} Page 1 of 50 510(k) SUMMARY for Atlantis® Abutments in Titanium (K250081) 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401, USA Contact Person: Laura Sobrin Telephone Number: 717-849-4434 Email: laura.sobrin@dentsplysirona.com Date Prepared: April 11, 2025 2. Device Name: - Proprietary Name: Atlantis® Abutments in Titanium - Classification Name: Abutment, Implant, Endosseous, Root-Form - CFR Number: 872.3630 - Device Class: Class II - Primary Product Code: NHA 3. Predicate/Reference Devices: The primary purpose of the Bundled Traditional 510(k) premarket notification is to modify the labeling of the Atlantis® Abutments in Titanium to update the safety in an MR environment to indicate MR Conditional. This includes a total of 11 implant system compatibilities/clearances. The predicate device, K193529, which is an Atlantis® Abutment specifically compatible with the MIS Conical Connection implant system, represents the most recently cleared implant system compatibility for the Atlantis® Abutments in Titanium. The 510(k) clearances for the additional implant system compatibilities bundled in this submission are referred to as reference devices. Therefore, the proposed devices are modifications to the predicate device, K193529, and modification to the additional 10 implant system compatibilities/clearances, reference devices, listed below. {6} | Predicate Device Name – Implant system compatibility included in this submission for MR Conditional labeling update | 510(k) | Product Code and Classification Reg | Company Name | | --- | --- | --- | --- | | Atlantis® Abutment for MIS Conical Connection Implants | K193529 | NHA, Abutment, Implant, Dental, Endosseous 872.3630, Endosseous dental implant abutment | Dentsply Sirona Inc. | | Reference Device Name – Additional implant system compatibilities bundled in this submission for MR Conditional labeling update | 510(k) | Product Code and Classification Reg | Company Name | | --- | --- | --- | --- | | Atlantis® Abutment for Conelog Implant | K161030 | NHA, 872.3630 | Dentsply Sirona Inc. | | Atlantis® Abutment for NobelActive 3.0 | K151039 | NHA, 872.3630 | Dentsply Sirona Inc. | | Atlantis® Abutments for Astra Osseospeed 3.0 Implant System (currently marketed as OsseoSpeed/OsseoSpeed TX) | K081666 | NHA, 872.3630 | Astra Tech Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for BioHorizons Implant | K073258 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Astra Implant (currently marketed as OsseoSpeed/OsseoSpeed TX) | K070833 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for 3i Certain MicroMini Implant | K062197 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for 3i MicroMini Implant (also cleared compatibility with Branemark NP and BioHorizons NP) | K062069 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Astra Implant (currently marketed as OsseoSpeed/OsseoSpeed TX) | K051652 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for 3i Certain Implant | K051011 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment and Atlantis® Abutment Screw (cleared compatibility with Biomet Osseotite, Branemark RP/WP, and BioHorizons RP/WP) | K981858 | DZE, Implant, endosseous, root-form* 872.3640, Endosseous dental implant | Atlantis Components Inc., now Dentsply Sirona Inc. | *This is an older 510(k) where the Atlantis® Abutment was cleared under product code DZE, Implant, Endosseous, Root-form In addition to the above reference devices, the below reference devices are added to close the gap in technological characteristic differences between the predicate device and the proposed modified Atlantis® Abutment in Titanium implant system compatibilities. {7} | Reference Device Name | 510(k) | Product Code & Classification Reg | Company Name | Reason for inclusion | | --- | --- | --- | --- | --- | | OmniTaper EV Dental Implants; DS Implants with EV connection | K221094 | DZE, 872.3640 NHA, 872.3630 | Dentsply Sirona Inc. | Reference to MR testing on worst-case implants/abutments devices Reference to same reprocessing instructions (reference device TiDesign EV) | | DS Implants abutments with EV Connection | | | | | | Atlantis® Suprastructures | K151439 | NHA, 872.3630 | Dentsply Sirona Inc. | Similar Angulated Screw Access (ASA) feature | | 3Shape Abutment Designer Software | K151455 | PNP, 872.3630 | 3Shape A/S | The 3Shape software is part of the additional proposed workflow that allows the user to design the Atlantis Abutment within the Atlantis design limitations prior to manufacturing by Dentsply Sirona. | 4. Description of Device: Atlantis® Abutment in Titanium refers to the following abutments that are the subject of this 510(k): - Atlantis® Abutment, - Atlantis® Crown Abutment, - Atlantis® Conus Abutment, and - Atlantis® Healing Abutment. The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities. Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities. The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment in Titanium, including the Conus abutments and Healing abutments, are available in Titanium or Gold-shaded Titanium (titanium nitride layer applied using PVD (Physical Vapor Deposition)). The Crown Abutment is only available in Titanium. Page 3 of 50 {8} The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient. The Atlantis® Conus abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis. The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase. Unless otherwise noted in this summary, the design envelope has remained unchanged from the previously cleared systems. Parameters such as gingival height and abutment diameter are dependent on the different implant system compatibilities. Table 4.1 below includes the main specifications of the Atlantis® Abutments in Titanium that are subject of this submission. Table 4.1 Specifications of the Atlantis® Abutments in Titanium that are subject of this submission | Item | Specification | | --- | --- | | Atlantis® Abutment in Titanium for MIS V3 and C1 implants | | | Abutment platform diameter | Ø2.765, 2.76, 3.16, 4.01 mm | | Compatible Implant diameter | V3: Ø3.3, 3.9, 4.3, 5.0 mm; C1: Ø3.3, 3.75, 4.2, 5.0 mm | | Compatible Implant System | MIS V3 (K163349), MIS C1 (K172505) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for Conelog implants | | | Abutment platform diameter | Ø2.80, 3.00, 3.80 mm | | Compatible Implant diameter | Ø 3.3, 3.8, 4.3, 5.0 mm | | Compatible Implant System | Conelog Screw-Line Implant 3.3, 3.8/4.3, 5.0 (K113779) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for Nobel Active 3.0 implants | | | Abutment platform diameter | Ø2.461 mm | | Compatible Implant diameter | 3.0 mm | | Compatible Implant System | Nobel Biocare Active Implant 3.0 (K102436) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for OsseoSpeed 3.0 implants | | | Abutment platform diameter | Ø2.330 mm | | Compatible Implant Diameter | Ø 3.0 mm | | Compatible Implant System | OsseoSpeed 3.0 – Yellow, OsseoSpeed TX 3.0 - Yellow (K080396, K101732) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for BioHorizons implants | | | Abutment platform diameter | Ø3.434, 4.399, 5.644 mm | | Compatible Implant Diameter | 3.5, 4.5, 5.7 mm | | Compatible Implant System | BioHorizons Internal 3.5, 4.5, 5.7 (K042429) | | Connection | Internal Hex, Tapered Internal | | Atlantis® Abutment in Titanium for OsseoSpeed 3.5 and 4.0 mm implants | | | Abutment platform diameter | Ø2.866 mm | | Compatible Implant Diameter | 3.5, 4.0 mm | {9} | Item | Specification | | --- | --- | | Compatible Implant System | OsseoSpeed 3.5/4.0 - Aqua, OsseoSpeed TX 3.5/4.0 - Aqua (K053384, K101732) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for Biomet 3i Certain implants | | | Abutment platform diameter | Ø3.404 mm | | Compatible Implant Diameter | 3.25, 3.4 mm | | Compatible Implant System | Biomet 3i Certain 3.25, 4/3, Biomet 3i Certain Prevail 3/4/3 (3.4), 4/3 (K051461) | | Connection | Internal Hexagon Connection | | Atlantis® Abutment in Titanium for Biomet, Nobel Biocare, and BioHorizons implants | | | Abutment platform diameter | Biomet: Ø 4.056 mm Nobel: Ø 3.476 mm BioHorizons: 3.708 mm | | Compatible Implant Diameter | Biomet: 3.25, 3.75, 4.0 mm Nobel: 3.3 mm BioHorizons: 3.5 mm | | Compatible Implant System | 3i Osseotite Tapered and Parallel Walled (K014235, K031475, K041402) Nobel Biocare Branemark System NP 3.3 (K050705) BioHorizons 3.5 (K010458) | | Connection | External Hexagon Connection | | Atlantis® Abutment in Titanium for Osseospeed/Osseospeed TX implants | | | Abutment platform diameter | Ø 3.368, 3.865 mm | | Compatible Implant Diameter | Ø 4.0, 4.5, 5.0 mm | | Compatible Implant System | OsseoSpeed 4.0 Blue (Previous) (K041492) OsseoSpeed/OsseoSpeed TX 4.5, 5.0 - Lilac (K053384, K101732) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for 3i Certain implants | | | Abutment platform diameter | Ø 4.012, 4.942, 5.951 mm | | Compatible Implant Diameter | Ø 4.0, 5.0, 6.0 mm | | Compatible Implant System | Biomet 3i Certain 4.0, 5.0, 6.0, 5/4, Biomet 3i Certain Prevail 4/5/4, 5/6/5, 5/4, 6/5, Biomet Certain XP 4/5, 5/6 (K031475) | | Connection | Internal hexagon connection | | Atlantis® Abutment in Titanium for Biomet, Nobel Biocare, and BioHorizons implants | | | Abutment platform diameter | Biomet: 4.056, 4.978, 5.985 mm Nobel: 4.069, 5.033 mm BioHorizons: 4.242, 5.258 mm | | Compatible Implant Diameter | Biomet: 3.75, 4.0, 5.0, 6.0 mm Nobel: 3.75, 4.0, 5.0, 5.5 mm BioHorizons: 4.0, 5.0 mm | | Compatible Implant System | Biomet 3i Osseotite 3.75, 4.0, 5.0, 6.0, Biomet Osseotite XP 4/5, 5/6 (K983347) Branemark RP 3.75 and 4.0, Branemark WP 5.0 and 5.5, (K974828, K022562) BioHorizons External 4.0 and 5.0 (K972313) | | Connection | External Hexagon Connection | {10} 5. Intended Use and Indications for Use: The proposed devices and the predicate device, Atlantis® Abutment for MIS Conical Connection Implants (K193529), have the same intended use. The proposed devices are intended to be used in the upper or lower jaw for supporting tooth replacements to restore chewing function. The Indications for Use of the proposed devices are similar to those of the predicate device. Refer to Table 5.1 for a comparison. Table 5.2 includes additional tables that provide a comparison between the originally cleared Indications for Use and the proposed Indications for Use statement for each implant system compatibility, and a discussion on the differences. Page 6 of 50 {11} Table 5.1: Comparison of the Intended Use/Indications for Use of the Proposed Devices Atlantis® Abutments in Titanium and the Predicate Device (K193529) | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutment for MIS Conical Connection Implants (K193529) | Discussion | | --- | --- | --- | --- | | Intended use | Dental implant abutments are intended to be used in the upper or lower jaw for supporting tooth replacements to restore chewing function. | Dental implant abutments are intended to be used in the upper or lower jaw for supporting tooth replacements to restore chewing function. | Same | | Indications for Use | Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. | The Atlantis® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented, or screw retained to the abutment. The abutment screw is intended to secure the Atlantis® Abutment to the endosseous implant. The Atlantis® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the Atlantis® Crown Abutment to the endosseous implant. The Atlantis® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the Atlantis® Conus Abutment to the endosseous implant. The Atlantis® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). “The prosthesis can be cemented, or screw retained to the abutment.” was removed as a crown cannot be screwed to an abutment. Restorations are always cemented to an abutment. The consolidated Indications for Use include each implant system compatibility information by implant system manufacturer. | {12} | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutment for MIS Conical Connection Implants (K193529) | Discussion | | --- | --- | --- | --- | | | The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 3.0 (Yellow), 3.5, 4.0 (Aqua), 4.5, 5.0 (Lilac), 4.0 (Blue - Previous) Abutment Platform Diameter (in mm): 2.330 (Yellow), 2.866 (Aqua), 3.865 (Lilac), 3.368 (Blue - Previous) Implant Manufacturer: MIS Implant Technologies Inc. Implant System: V3 (NP, SP), C1 (NP, SP, WP) Implant Diameter (in mm): V3: 3.30 (NP), 3.90, 4.3, 5.0 (SP); C1: 3.30 (NP), 3.75, 4.2 (SP), 5.0 (WP) Abutment Platform Diameter (in mm): V3: 2.765 (NP), 3.16 (SP); C1: 2.76 (NP), 3.16 (SP), 4.01 (WP) Implant Manufacturer: Altatec GmbH Implant System: Conelog Screw-Line Implant Implant Diameter (in mm): 3.3, 3.8, 4.3, 5.0 Abutment Platform Diameter (in mm): 2.80 (3.3), 3.00 (3.8, 4.3), 3.80 (5.0) Implant Manufacturer: Nobel Biocare Implant System: NobelActive Implant Diameter (in mm): 3.0 Abutment Platform Diameter (in mm): 2.461 Implant System: Branemark System (NP, RP, WP) Implant Diameter (in mm): 3.3 (NP), 3.75, 4.0 (RP), 5.0, 5.5 (WP) Abutment Platform Diameter (in mm): 3.476 (NP), 4.069 (RP), 5.033 (WP) Implant Manufacturer: BioHorizons Implant System: Prodigy System Internal/Tapered Internal Implant Diameter (in mm): 3.5, 4.5, 5.7 | Atlantis® Healing Abutment to the endosseous implant. Atlantis® Abutment is compatible with MIS Conical Connection implant from MIS Implant System. Atlantis® products are compatible with the implants shown in the table below. Implant manufacturer – MIS-IMPLANT TECHNOLOGIES INC Trade Name- Abutment Platform Diameter – Implant Diameter Atlantis Abutment for MIS V3 NP - Ø2.765mm -V3: Ø3.30 mm Atlantis Abutment for MIS C1 NP - Ø2.76mm - C1: Ø3.30 mm Atlantis Abutment for MIS C1 & V3 SP - Ø3.16mm - C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm Atlantis Abutment for MIS C1 WP - Ø4.01mm C1: Ø5.0 mm | | Page 8 of 50 {13} | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutment for MIS Conical Connection Implants (K193529) | Discussion | | --- | --- | --- | --- | | | Abutment Platform Diameter (in mm): 3.434 (3.5), 4.399 (4.5), 5.644 (5.7) Implant System: Maestro Implant Diameter (in mm): 3.5, 4.0, 5.0 Abutment Platform Diameter (in mm): 3.708 (3.5), 4.242 (4.0), 5.258 (5.0) Implant Manufacturer: Biomet 3i Implant System: Certain, Certain Prevail, Certain XP Implant Diameter (in mm): Certain: 3.25, 4, 5, 6; Certain Prevail: 3.4, 4, 5; Certain XP: 5, 6 Abutment Platform Diameter (in mm): 3.404 (3.25, 3.4), 4.012 (4), 4.942 (5), 5.951 (6) Implant System: Osseotite Tapered and Osseotite Parallel Walled Implant Diameter (in mm): 3.25, 3.75, 4.0, 5.0, 6.0 Abutment Platform Diameter (in mm): 4.056 (3.25, 3.75, 4.0), 4.978 (5.0), 5.985 (6.0) | | | Page 9 of 50 {14} Table 5.2: Comparison between the originally cleared Indications for Use and the proposed Indications for Use statement for each Atlantis Abutments in Titanium | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | K193529 | The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System. | Atlantis Abutment & Atlantis Abutment MillingThe Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.Atlantis Crown AbutmentThe Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.Atlantis Conus AbutmentThe Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.Atlantis Healing AbutmentThe Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455).Removed incorrect statement around “The prosthesis [crown] can be cemented or screw retained to the abutment”. This was removed because a crown cannot be screwed to an abutment. Crowns are always cemented to an abutment. | {15} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | ATLANTIS® products are compatible with the implants shown in the table below. | two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. | | | | Implant manufacturer - MIS-IMPLANT TECHNOLOGIES INC | Implant Manufacturer: MIS Implant Technologies Inc. | | | | Trade Name- Abutment Platform Diameter-Implant Diameter | Implant System: V3 (NP, SP), C1 (NP, SP, WP) | | | | Atlantis Abutment for MIS V3 NP - Ø2.765mm -V3: Ø3.30 mm | Implant Diameter (in mm): V3: 3.30 (NP), 3.90, 4.3, 5.0 (SP); C1: 3.30 (NP), 3.75, 4.2 (SP), 5.0 (WP) | | | | Atlantis Abutment for MIS C1 NP - Ø2.76mm - C1: Ø3.30 mm | Abutment Platform Diameter (in mm): V3: 2.765 (NP), 3.16 (SP); C1: 2.76 (NP), 3.16 (SP), 4.01 (WP) | | | | Atlantis Abutment for MIS C1 & V3 SP - Ø3.16mm - C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm | | | | | Atlantis Abutment for MIS C1 WP - Ø4.01 mm - C1: Ø5.0 mm | | | | K161030 | The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for | Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Aplantis Abutment | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed incorrect statement around “The prosthesis [crown] can be cemented or screw retained to the abutment”. This was removed because a crown cannot be screwed to an abutment. Crowns are always cemented to an abutment. Added Healing Abutment indications. | Page 11 of 50 {16} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant. ATLANTIS™ products are compatible with the implants shown in the table below. Implant Manufacturer - Trade Name - Implant Diameter - Abutment Platform Diameter Altatec GmbH CONELOG SCREW-LINE Implant Ø3.3, 3.8, 4.3, 5.0 mm Ø3.3, 3.8, 4.3, 5.0 mm | screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Altatec GmbH Implant System: Conelog Screw-Line Implant Implant Diameter (in mm): 3.3, 3.8, 4.3, 5.0 Abutment Platform Diameter (in mm): 2.80 (3.3), 3.00 (3.8, 4.3), 3.80 (5.0) | Correction was made to the abutment platform diameter since the original indications repeated the implant diameter measurements instead of specifically referring to the abutment platform diameter measurements. | | K151039 | The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed incorrect statement around “The prosthesis [crown] can be cemented or screw retained to the | Page 12 of 50 {17} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS™ Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant. ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant. | The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Nobel Biocare Implant System: NobelActive Implant Diameter (in mm): 3.0 Abutment Platform Diameter (in mm): 2.461 | abutment”. This was removed because a crown cannot be screwed to an abutment. Crowns are always cemented to an abutment. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Added Healing Abutment indications. Although this specific implant system compatibility does not have a Conus Abutment (Conus Abutment was cleared but now discontinued), the Atlantis Conus Abutment is still included in the general indications as all Atlantis Abutments in Titanium share the same indications and Instructions for Use. The user will refer to the compatibility chart to confirm which abutments are available with which implant system. | | K081666 | The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the maxillary lateral incisors and mandibular lateral and central incisors. The | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the | Page 13 of 50 {18} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the Implant. | or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 3.0 (Yellow) Abutment Platform Diameter (in mm): 2.330 (Yellow) | 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. This abutment is not offered as a Conus Abutment. However, all Atlantis Abutments in Titanium share the same indications and Instructions for Use. The user will refer to the compatibility chart to confirm which abutments are available with which implant system. Limitations for use statement (“limited to maxillary lateral incisors and mandibular lateral and central incisors”) specific to small diameters such as the Atlantis Abutment for OsseoSpeed/OsseoSpeed TX 3.0 are now partially captured in the Contraindications section of the Instructions for Use. In addition, this limitation for use is fully captured in the implant system Indications for Use (K080396, K101732). The implant system indications and placement | Page 14 of 50 {19} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | | limitations dictate where the abutment will be placed. Therefore, the limitations for use are not repeated in the indications. The special note was removed altogether for the following reasons: - The language regarding surgical technique (early loading protocol) is more appropriate for the implant system indications and has therefore been removed from the abutment indications. - The highly angled abutment limitations were moved to the Contraindications section of the Instructions for Use. | | K073258 | The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant. | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Added Healing Abutment, Conus Abutment, and Crown Abutment | Page 15 of 50 {20} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: BioHorizons Implant System: Prodigy System Internal/Tapered Internal Implant Diameter (in mm): 3.5, 4.5, 5.7 Abutment Platform Diameter (in mm): 3.434 (3.5), 4.399 (4.5), 5.644 (5.7) | indications. The dental implant system diameter was updated to be consistent with the implant manufacturer platform diameter information. The implant body diameters are 3.5 mm, 4.0 mm, 5.0 mm and 6.0 mm, which correspond to the implant manufacturer’s designation as follows: 3.5 = 3.5; 4.0 = 4.5; and 5.0/6.0 = 5.7. The special note was removed altogether for the following reasons: - The language regarding surgical technique (early loading protocol) is more appropriate for the implant system indications and has therefore been removed from the abutment indications. - The highly angled abutment limitations were moved to the Contraindications section of the Instructions for Use. | | K070833 | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed^{TM} 3.5(S) mm, 4.0(S) mm Internal Hex Implants. Please note: This device may be used in an early load | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. | Page 16 of 50 {21} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant. | restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 3.5, 4.0 (Aqua) Abutment Platform Diameter (in mm): 2.866 (Aqua) | Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. The special note was removed altogether for the following reasons: - The language regarding surgical technique (early loading protocol) is more appropriate for the implant system indications and has therefore been removed from the abutment indications. - The highly angled abutment limitations were moved to the Contraindications section of the Instructions for Use. | | K062197 | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The | Page 17 of 50 {22} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | The Atlantis Abutment for 3i Certain MicroMini Implant is compatible with 3i Osseotite NT® Certain and Parallel Walled Implants both with 3.25 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant fixture. | Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Biomet 3i Implant System: Certain, Certain Prevail Implant Diameter (in mm): 3.25, 3.4 Abutment Platform Diameter (in mm): 3.404 | prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Biomet 3i implant platform of 3.25 corresponds to the 3.4 implant body size. Therefore, implants with designation 3.4, 3.25, or 3/4 correspond to the same implant size and therefore are compatible with the same Atlantis Abutment. The 3i Certain MicroMini Implant naming convention is no longer used by the implant manufacturer. Reference to the implant system has been updated to indicate 3i Certain and Certain Prevail implant system. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. The special note was removed altogether for the following reasons: - The language regarding surgical technique (early loading protocol) is more appropriate for the implant system indications and has therefore been removed from the abutment indications. - The highly angled abutment limitations were moved to the | Page 18 of 50 {23} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | | Contraindications section of the Instructions for Use. | | K062069 | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: Mk III 3.3m, Threaded IIL Series 3.3mm, IIL Immediate Impression 3.25mm, Cylindrical BL Series 325mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterugold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegram T External 3.25mm. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant. | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing | This Atlantis Abutment is not available as “Atlantis Abutment Milling”. Since the Indications for Use are generic for all proposed Atlantis Abutments in Titanium subject of this submission, the Atlantis Abutment Milling is part of the indications. The user will use the compatibility chart to confirm which abutments are available for design in 3Shape (Atlantis Abutment Milling). Removed the statement around “The prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Many of the implant systems originally cleared are discontinued. The compatibilities that remain active and included in the proposed Indications for Use are: • BioHorizons Maestro (which was listed in the K062069 indications as “Maestro™ 3.5mm”) • Osseotite Tapered and Osseotite Parallel Walled (which was listed in the K062069 indications as “Osseotite NT Certain and Parallel Walled Implants both | Page 19 of 50 {24} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | Abutment to the endosseous implant. Implant Manufacturer: BioHorizons Implant System: Maestro Implant Diameter (in mm): 3.5 Abutment Platform Diameter (in mm): 3.708 Implant Manufacturer: Biomet 3i Implant System: Osseotite Tapered and Osseotite Parallel Walled Implant Diameter (in mm): 3.25 Abutment Platform Diameter (in mm): 4.056 Implant Manufacturer: Nobel Biocare Implant System: Branemark System (NP) Implant Diameter (in mm): 3.3 Abutment Platform Diameter (in mm): 3.476 | with 3.25mm diameter”) • Branemark (which was listed in the indications as “MK III 3.3mm”) The special note was removed altogether for the following reasons: - The language regarding surgical technique (early loading protocol) is more appropriate for the implant system indications and has therefore been removed from the abutment indications. - The highly angled abutment limitations were moved to the Contraindications section of the Instructions for Use. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. This abutment is not offered as a Healing Abutment. All Atlantis Abutments in Titanium share the same indications and Instructions for Use. The user will refer to the compatibility chart to confirm which abutments are available with which implant system. | | K051652 | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cemented | Page 20 of 50 {25} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Dentsply Sirona Implant System: OsseoSpeed/OsseoSpeed TX Implant Diameter (in mm): 4.5, 5.0 (Lilac), 4.0 (Blue - Previous) Abutment Platform Diameter (in mm): 3.865 (Lilac), 3.368 (Blue - Previous) | retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. Specified the compatible implant system, implant diameter, and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. | | K051011 | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the | Page 21 of 50 {26} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Biomet 3i Implant System: Certain: 4, 5, 6; Certain Prevail: 4, 5; Certain XP: 5, 6 | submission to demonstrate that the same design limitations exist between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cemented retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. Added Healing Abutment, Conus Abutment, and Crown Abutment indications. Specified the compatible implant system, implant diameter, and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. | Page 22 of 50 {27} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | Implant Diameter (in mm): 4, 5, 6 Abutment Platform Diameter (in mm): 4.012 (4), 4.942 (5), 5.951 (6) | | | K981858 | The Atlantis Abutment is used to connect an implanted fixture to a restoration | The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant. Atlantis Crown Abutment The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant. Atlantis Conus Abutment The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant. Atlantis Healing Abutment The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or | Originally cleared indications are very generic. Complete rewrite of indications based on historical changes made to the Atlantis Abutments. This Atlantis Abutment is not available as “Atlantis Abutment Milling”. Since the Indications for Use are generic for all proposed Atlantis Abutments in Titanium subject of this submission, the Atlantis Abutment Milling is part of the indications. The user will use the compatibility chart to confirm which abutments are available for design in 3Shape (Atlantis Abutment Milling). Added Healing Abutment, Conus Abutment, and Crown Abutment indications. This abutment is not offered as a Healing Abutment. All Atlantis Abutments in Titanium share the same indications and Instructions for Use. The user will refer to the compatibility chart to confirm which abutments are available with which implant system. Specified the compatible implant system, implant diameter, and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. | Page 23 of 50 {28} | 510(k) | Predicate/Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: BioHorizons Implant System: Maestro Implant Diameter: 4.0, 5.0 mm Abutment Platform Diameter: 4.242, 5.258 mm Implant Manufacturer: Biomet 3i Implant System: Osseotite Tapered and Osseotite Parallel Walled Implant Diameter: 3.75, 4.0, 5.0, 6.0 mm Abutment Platform Diameter: 4.056 (3.75, 4.0), 4.978 (5.0), 5.985 (6.0) Implant Manufacturer: NobelBiocare Implant System: Branemark System (RP, WP) Implant Diameter (in mm): 3.75, 4.0 (RP), 5.0, 5.5 (WP) Abutment Platform Diameter (in mm): 4.069 (RP), 5.033 (WP) | The implant system is referred to as “3i Standard threaded” in K981858 and is now referred to as “Osseotite” and “Osseotite XP”. K981858 referred to the implant system as “Branemark RP” and “Branemark WP” which is consistent with the current naming convention. K981858 referred to the BioHorizons implant as Maestro which is consistent with the current naming convention. | Page 24 of 50 {29} Page 25 of 50 6. Technological Comparison: The primary purpose of the Bundled Traditional 510(k) premarket notification is to modify the labeling of the Atlantis® Abutments in Titanium to update the safety in an MR environment to indicate MR Conditional. The Abutments will be changed from MR Not Evaluated to MR Conditional. The labeling change reflects the requirements in the FDA guidance document, “Testing and Labeling Devices for Safety in the Magnetic Resonance (MR) Environment” and ensures that the clinician has the necessary information to communicate to the patient regarding the MR Safety of the proposed devices. In addition to the MR Conditional labeling changes, internally documented changes and proposed modifications are included in the submission. **Angulated Screw Access (ASA)** Dentsply Sirona added the Angulated Screw Access (ASA) feature to some Atlantis® Abutments, as reviewed in reference device K151439, Atlantis® Suprastructures. The angulated screw access allows the clinician to access the screw access channel from the lingual side, which facilitates the installation procedure of the abutment. **Healing, Conus and Crown Abutment offering** Dentsply Sirona expanded the abutment offering to include Healing Abutments, Conus Abutments, and Crown Abutments that were not originally cleared with some Atlantis® Abutments. This offering is already cleared for the Atlantis® Abutment for MIS Conical Connection Implants in predicate device, K193529. The additional abutments (Healing, Conus, and Crown) are within the design envelope of the corresponding cleared Atlantis® Abutment implant system compatibilities and have the same mating geometry to the implant, which have been tested per ISO 14801 in respective original clearances. **Screw and abutment diameter modifications** Minor modification was made to some of the abutment screws since the original clearance of the Atlantis® Abutments in Titanium. These changes were made to standardize dimensions across the various custom abutment screws to simplify the procurement and quality control process. Upon review, the changes to the screws did not cause an interference with the internal geometry of the abutment and the modified screws are considered as safe and effective as the predicate device and reference device screws. Limited to two implant system compatibilities (reference devices K073258 and K051652), the abutment diameter was slightly modified. Compatibility analysis was performed and the results indicate that the modifications do not result in a new worst-case for fatigue testing. Fatigue testing submitted in the original submissions remains valid. **Additional Compatibility** Added compatibility of existing Atlantis® Abutments in Titanium (K081666, K070833, K051652) with the Osseospeed TX implant system (K101732). The OsseoSpeed TX implant system has the same internal geometry as the OsseoSpeed Implant System (K080396, K053384, K041492) and therefore the Atlantis® Abutments in Titanium for OsseoSpeed/OsseoSpeed TX are compatible with both implant systems. **Atlantis Abutment Milling (Design in 3Shape)** Some Atlantis® Abutments (predicate device, K193529, and reference devices K151039, {30} K161030, K081666, K073258, K070833, K062197, K051652, K051011) can be designed by the user via 3Shape (3Shape Abutment Designer Software, K151455).…
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