Atlantis® Abutments in Titanium

K252343 · Dentsply Sirona · NHA · Dec 9, 2025 · Dental

Device Facts

Record IDK252343
Device NameAtlantis® Abutments in Titanium
ApplicantDentsply Sirona
Product CodeNHA · Dental
Decision DateDec 9, 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) fabricated via CAD/CAM; designed based on patient dental models to connect endosseous implants to prosthetic restorations. Clinicians prescribe abutment geometry; Dentsply Sirona manufactures via internal CAD/CAM or via 3Shape Abutment Designer Software (K151455) within a locked design library. Abutments are titanium or gold-shaded titanium (PVD TiN layer). Used in dental clinics to restore chewing function. Output is a customized abutment secured to the implant via a screw. Benefits include patient-specific fit and aesthetic outcomes. MR Conditional labeling update.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fatigue testing per ISO 14801, biocompatibility per ISO 10993-1, and software validation of the design envelope within 3Shape Abutment Designer Software.

Technological Characteristics

Materials: Titanium alloy (ASTM F136), Gold-shaded Titanium (PVD TiN). Connections: Internal/External Hex, Conical, Tri-channel, Square, Octagon. Manufacturing: CAD/CAM. Software: Locked design library. Sterilization: Moist heat.

Indications for Use

Indicated for partially or completely edentulous patients requiring prosthetic support via endosseous dental implants in the mandible or maxilla. Supports single/multiple tooth prostheses, removable multiple tooth prostheses (Conus), or temporary soft tissue healing (Healing Abutment).

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 December 9, 2025 Dentsply Sirona Laura Sobrin Sr. Technical RA Manager 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401 Re: K252343 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: July 25, 2025 Received: December 1, 2025 Dear Laura Sobrin: 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} K252343 - Laura Sobrin 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} K252343 - Laura Sobrin 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: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K252343 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: AstraTech EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8 ((L) Blue), 5.4 ((XL) Brown) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) Implant System: PrimeTaper EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8, 5.4 ((L) Blue) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L) Implant System: OmniTaper EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.4 ((S) Purple), 3.8 ((M) Yellow), 4.5 ((L) Blue), 5.5 ((XL) Brown) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) Implant System: AstraTech EV Profile Implant Diameter (in mm): 4.2, 4.8 Abutment Platform Diameter (in mm): 3.152 (4.2), 3.641 (4.8) Implant System: Ankylos C/X Implant Diameter (in mm): 3.5, 4.5, 5.5, 7 Abutment Platform Diameter (in mm): 2.520 Implant Manufacturer: MIS Implant Technologies Inc. Implant System: M4 and Seven (NP, SP, WP) Implant Diameter (in mm): 3.30 (NP), 3.75, 4.2 (SP), 5.0, 6.0 (WP) Abutment Platform Diameter (in mm): 3.10 (NP), 3.536 (SP), 4.514 (WP) FORM FDA 3881 (8/23) PISC Publishing Services (301) 443-6740 {4} Implant Manufacturer: Hiossen Implant System: Hiossen ET III SA Fixture Implant Diameter (in mm): 3.5 (Mini), 4.0, 4.5, 5.0, 6.0, 7.0 (Regular) Abutment Platform Diameter (in mm): 2.797 (Mini), 3.350 (Regular) Implant Manufacturer: Nobel Biocare Implant System: Nobel Active/Nobel Replace Conical Connection (NP, RP, WP) Implant Diameter (in mm): 3.5 (NP), 4.3, 5.0 (RP), 5.5 (WP) Abutment Platform Diameter (in mm): 2.939 (NP), 3.334 (RP), 4.389 (WP) Implant System: Nobel Replace (tri-channel connection) Implant Diameter (in mm): 3.5 (NP), 4.3 (RP), 5.0 (WP), 6.0 Abutment Platform Diameter (in mm): 3.53 (NP), 4.30 (RP), 5.00 (WP), 5.99 (6.0) Implant Manufacturer: Straumann Implant System: Bone Level Cross-Fit Implant Diameter (in mm): 3.3 (NC), 4.1, 4.8 (RC) Abutment Platform Diameter (in mm): 2.766 (NC), 3.295 (RC) Implant System: Standard/Standard Plus Implant Diameter (in mm): 3.3, 4.1, 4.8 (RN), 4.8 (WN) Abutment Platform Diameter (in mm): 4.771 (RN), 6.474 (WN) Implant System: Standard Plus Implant Diameter (in mm): 3.3 (NN) Abutment Platform Diameter (in mm): 3.491 Implant Manufacturer: Zimmer Dental Implant System: Tapered Screw-Vent Implant Diameter (in mm): 3.7, 4.1, 4.7, 6.0 Abutment Platform Diameter (in mm): 3.536 (3.7, 4.1), 4.514 (4.7), 5.720 (6.0) Implant System: Tapered Screw-Vent (Friction Fit) Implant Diameter (in mm): 3.7, 4.1, 4.7, 6.0 Abutment Platform Diameter (in mm): 3.413 (3.7, 4.1), 4.385 (4.7), 5.612 (6.0) Implant System: Screw-Vent Implant Diameter (in mm): 3.7, 4.7 Abutment Platform Diameter (in mm): 3.536 (3.7), 4.514 (4.7) Implant System: Screw-Vent (Friction Fit) Implant Diameter (in mm): 3.7, 4.7 Abutment Platform Diameter (in mm): 3.413 (3.7), 4.385 (4.7) 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. FORM FDA 3881 (8/23) Page 2 of 3 PSC Publishing Services (301) 443-6740 {5} 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 (8/23) Page 3 of 3 {6} Page 1 of 57 510(k) SUMMARY for Atlantis® Abutments in Titanium (K252343) 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: December 5, 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 indicate MR Conditional. This includes a total of 10 implant system compatibilities/clearances. The predicate device, K250081, Atlantis® Abutments in Titanium, represents the latest version of the Atlantis® Abutments in Titanium and shares the same intended use, similar Indications for Use, and same design envelope as the proposed abutments. In addition to the change in MR Conditional labeling, the submission also includes changes shared across the abutment family that were internally documented and therefore reflect the current version of the abutments, while some changes are new, generalizable changes requested to be cleared within this 510(k). Therefore, this submission proposes the same changes made in K250081 for a different group of Atlantis® Abutments in Titanium, with a few additional changes specific to the subject group of abutments. There are also some minor changes made to the abutments in this submission which were not completely covered in the K250081 clearance. The implant system compatibilities being modified and bundled in this submission are referred to as reference devices. {7} | 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 | K250081 | NHA, Abutment, Implant, Dental, Endosseous 872.3630, Endosseous dental implant abutment | Dentsply Sirona Inc. | | Reference Device Name – Implant system compatibilities bundled in this submission for MR Conditional labeling update | 510(k) | Product Code and Classification Reg | Company Name | | --- | --- | --- | --- | | Atlantis® Abutment for MIS Implant | K172225 | NHA, 872.3630 | Dentsply Sirona Inc. | | Atlantis® Abutment for Hiossen ET Implant | K160626 | NHA, 872.3630 | Dentsply Sirona Inc. | | Atlantis® Abutment for Astra Tech Profile EV Implants and OsseoSpeed EV 3.0 Implants | K130999 | NHA, 872.3630 | Dentsply Implants Manufacturing GmbH, part of Dentsply Sirona Inc. | | Astra Tech (OsseoSpeed) EV stock abutments compatible with OsseoSpeed EV implants | K111287 | DZE, 872.3640 NHA, 872.3630 | AstraTech AB, now Dentsply Sirona Inc. | | Atlantis® Abutment for Ankylos Implant | K101004 | NHA, 872.3630 | Astra Tech Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Nobel Biocare Implant | K093483 | NHA, 872.3630 | Astra Tech Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Straumann Implant | K083871 | NHA, 872.3630 | Astra Tech Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Nobel Replace Implant | K053654 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Zimmer Implant | K053373 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | | Atlantis® Abutment for Straumann Implant | K050052 | NHA, 872.3630 | Atlantis Components Inc., now Dentsply Sirona Inc. | 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. | Reference Device Name | 510(k) | Product Code & Classification Reg | Company Name | Reason for inclusion | | --- | --- | --- | --- | --- | | 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. This workflow was cleared in K250081 and this submission proposes to expand this to the abutments | {8} | Reference Device Name | 510(k) | Product Code & Classification Reg | Company Name | Reason for inclusion | | --- | --- | --- | --- | --- | | | | | | bundled in this submission. | | PrimeTaper EV Dental Implant | K210610 | DZE, 872.3630 | Dentsply Sirona Inc. | Includes fatigue testing of the Atlantis Abutments for EV connection (reference device K111287) with the PrimeTaper EV and AstraTech EV implant systems. | | OmniTaper EV | K221094 | DZE, 872.3630 NHA, 872.3630 | Dentsply Sirona Inc. | Includes fatigue testing of the Atlantis Abutments for EV connection (reference device K111287) with the OmniTaper EV and AstraTech EV implant systems. | | PrimeTaper EV Dental Implant (3.0) | K220841 | DZE, 872.3630 NHA, 872.3630 | Dentsply Sirona Inc. | Includes fatigue testing of the Atlantis Abutments for EV connection (reference device K130999) with the PrimeTaper EV 3.0 and AstraTech EV 3.0 implant systems. | 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, 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 57 {9} 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: List of specifications of proposed abutments | Item | Specification | | --- | --- | | Atlantis® Abutment in Titanium for MIS implants | | | Abutment platform diameter | Ø 3.10, 3.536, 4.514 mm | | Compatible Implant diameter | Ø 3.30, 3.75, 4.2, 5.0, 6.0 mm | | Compatible Implant System | MIS M4 and SEVEN implants (K040807, K103089, K180282) | | Connection | Internal Hexagon Connection | | Atlantis® Abutment in Titanium for Hiossen ET implants | | | Abutment platform diameter | Ø 2.797, 3.350 mm | | Compatible Implant diameter | Ø 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm | | Compatible Implant System | Hiossen Implant System (K140934) | | Connection | Internal Hexagon Connection | | Atlantis® Abutment in Titanium for AstraTech Profile EV implants and OsseoSpeed EV 3.0 implants | | | Abutment platform diameter | Ø 2.500 (EV), 3.152, 3.641 (Profile EV) mm | | Compatible Implant diameter | Ø 3.0 (EV), 4.2, 4.8 (Profile EV) mm | | Compatible Implant System | Astra Tech Profile EV implants (K130999) Astra Tech EV 3.0 implants (K120414) OmniTaper EV 3.0 implants (K221094) PrimeTaper EV 3.0 Implants (K220841) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for OsseoSpeed EV implants | | | Abutment platform diameter | Ø 2.900, 3.500, 4.100, 4.600 mm | | Compatible Implant Diameter | Ø 3.6, 4.2, 4.8, 5.4 mm (AstraTech EV and PrimeTaper EV Implants) Ø 3.4, 3.8, 4.5, 5.5 mm (OmniTaper EV implants) | {10} | Item | Specification | | --- | --- | | Compatible Implant System | AstraTech EV (K120414) PrimeTaper EV (K210610) OmniTaper EV (K221094) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for Ankylos implants | | | Abutment platform diameter | Ø 2.520 mm | | Compatible Implant Diameter | Ø 3.5, 4.5, 5.5, 7 mm | | Compatible Implant System | Ankylos X (indexed) Implant (K083805) Ankylos C (non-indexed) Implant (K083805) | | Connection | Internal connection (specifically with a 6-spline anti-rotation feature) | | Atlantis® Abutment in Titanium for Nobel Biocare implants | | | Abutment platform diameter | Ø 2.939 (NP), 3.334 (RP), 4.389 (WP) mm | | Compatible Implant Diameter | Ø 3.5 (NP), 4.3 (RP), 5.0 (RP), 5.5 (WP) mm | | Compatible Implant System | Nobel Active Internal Connection Implant (K071370) Nobel Replace Conical Connection Implant (K073142) | | Connection | Internal Conical Connection | | Atlantis® Abutment in Titanium for Straumann implants | | | Abutment platform diameter | Ø 2.766 (NC), 3.295 (RC), 3.491 (NN) mm | | Compatible Implant Diameter | Ø 3.3 (NC, NN), 4.1 (RC), 4.8 (RC) mm | | Compatible Implant System | Standard SLActive (K053088) | | Connection | BoneLevel: Internal Square Connection NarrowNeck: External Octagon Connection | | Atlantis® Abutment in Titanium for Nobel Replace implants | | | Abutment platform diameter | Ø 3.53 (NP), 4.30 (RP), 5.00 (WP), 5.99 mm | | Compatible Implant Diameter | Ø 3.5 (NP), 4.3 (RP), 5.0 (WP), 6.0 mm | | Compatible Implant System | Nobel Replace Implants (K023113, K020646) | | Connection | Internal Tri-Channel Connection | | Atlantis® Abutment in Titanium for Zimmer implants | | | Abutment platform diameter | Ø 3.536, 4.514, 5.720 mm (non-friction fit) Ø 3.413, 4.385, 5.612 mm (friction fit) | | Compatible Implant Diameter | Ø 3.7, 4.1, 4.7, 6.0 mm | | Compatible Implant System | Zimmer Dental Screw-Vent Implant System, tapered and non-tapered (K061410, K133339, K011028) | | Connection | Internal Hexagon Connection | | Atlantis® Abutment in Titanium for Straumann implants | | | Abutment platform diameter | Ø 4.771, 6.474 mm | | Compatible Implant Diameter | Ø 3.3, 4.1, 4.8 (RN with Ø 4.8 mm shoulder) Ø 4.8 (WN with Ø 6.5 mm shoulder) | | Compatible Implant System | Straumann Standard, Standard Plus and Tapered Effect Regular Neck and Wide Neck implants (K171784) | | Connection | Internal octagon connection | {11} 5. Intended Use and Indications for Use: The proposed devices and the predicate device, K250081, 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 57 {12} Table 5.1: Comparison of the Intended Use/Indications for Use of the Proposed Devices Atlantis® Abutments in Titanium and the Predicate Device (K250081) | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutments in Titanium (K250081) | 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 | 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. | Same except for the implant system compatibility specific information | {13} | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutments in Titanium (K250081) | Discussion | | --- | --- | --- | --- | | | 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: AstraTech EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8 ((L) Blue), 5.4 ((XL) Brown) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) Implant System: PrimeTaper EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8, 5.4 ((L) Blue) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L) Implant System: OmniTaper EV Implant Diameter (in mm): 3.0 ((XS) Green), 3.4 ((S) Purple), 3.8 ((M) Yellow), 4.5 ((L) Blue), 5.5 ((XL) Brown) Abutment Platform Diameter (in mm): 2.500 (XS), 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) Implant System: AstraTech EV Profile Implant Diameter (in mm): 4.2, 4.8 Abutment Platform Diameter (in mm): 3.152 (4.2), 3.641 (4.8) Implant System: Ankylos C/X Implant Diameter (in mm): 3.5, 4.5, 5.5, 7 Abutment Platform Diameter (in mm): 2.520 Implant Manufacturer: MIS Implant Technologies Inc. Implant System: M4 and Seven (NP, SP, WP) Implant Diameter (in mm): 3.30 (NP), 3.75, 4.2 (SP), 5.0, 6.0 (WP) Abutment Platform Diameter (in mm): 3.10 (NP), 3.536 | 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) Abutment Platform Diameter (in mm): 3.476 (NP), 4.069 (RP), 5.033 (WP) | | {14} | Item | Proposed Devices Atlantis® Abutments in Titanium | Predicate Device Atlantis® Abutments in Titanium (K250081) | Discussion | | --- | --- | --- | --- | | | (SP), 4.514 (WP) Implant Manufacturer: Hiossen Implant System: Hiossen ET III SA Fixture Implant Diameter (in mm): 3.5 (Mini), 4.0, 4.5, 5.0, 6.0, 7.0 (Regular) Abutment Platform Diameter (in mm): 2.797 (Mini), 3.350 (Regular) Implant Manufacturer: Nobel Biocare Implant System: Nobel Active/Nobel Replace Conical Connection (NP, RP, WP) Implant Diameter (in mm): 3.5 (NP), 4.3, 5.0 (RP), 5.5 (WP) Abutment Platform Diameter (in mm): 2.939 (NP), 3.334 (RP), 4.389 (WP) Implant System: Nobel Replace (tri-channel connection) Implant Diameter (in mm): 3.5 (NP), 4.3 (RP), 5.0 (WP), 6.0 Abutment Platform Diameter (in mm): 3.53 (NP), 4.30 (RP), 5.00 (WP), 5.99 (6.0) Implant Manufacturer: Straumann Implant System: Bone Level Cross-Fit Implant Diameter (in mm): 3.3 (NC), 4.1, 4.8 (RC) Abutment Platform Diameter (in mm): 2.766 (NC), 3.295 (RC) Implant System: Standard/Standard Plus Implant Diameter (in mm): 3.3, 4.1, 4.8 (RN), 4.8 (WN) Abutment Platform Diameter (in mm): 4.771 (RN), 6.474 (WN) Implant System: Standard Plus Implant Diameter (in mm): 3.3 (NN) Abutment Platform Diameter (in mm): 3.491 | 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) | | Page 9 of 57 {15} 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) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | K172225 | 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. | 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. | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists 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 | | | | | is not required to be removed from the 3Shape software (K151455). | {16} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | 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. ATLANTIS® Abutment for MIS implant is compatible with MIS implant from MIS Implant System. MIS short implants (6mm) are to be used only with straight abutments. ATLANTIS® products are compatible with the implants shown in the table below. Implant manufacturer - MIS-IMPPLANT TECHNOLOGIES INC Trade Name MIS Implant M4 & SEVEN Narrow Platform Abutment Platform Diameter Ø3.30 mm Implant Diameter Ø3.30 mm Trade Name MIS Implant M4 & SEVEN Standard Platform | 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: MIS Implant Technologies Inc. Implant System: M4 and Seven (NP, SP, WP) Implant Diameter (in mm): 3.30 (NP), 3.75, 4.2 (SP), 5.0, 6.0 (WP) Abutment Platform Diameter (in mm): 3.10 (NP), 3.536 (SP), 4.514 (WP) | was removed because a crown cannot be screwed to an abutment. Crowns are always cemented to an abutment. Added Healing Abutment indications. The statement related to short implants to be used with straight abutments was removed. This limitation for use is captured in the implant system Indications for Use where the short implants were cleared (K103089, K180282): “MIS short implants are to be used only with straight abutments”. The implant system indications and placement limitations dictate where the abutment will be placed. Therefore, the limitations for use are not repeated in the indications of the abutment. 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. Drawings included in reference device, K172225 correctly reflect the proposed abutment platform diameter information. Note: The Zirconia Abutments are not proposed to be modified in this submission as this Bundled submission is limited to Atlantis Abutments in Titanium. | Page 11 of 57 {17} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | Abutment Platform Diameter Ø3.75 and 4.2 mm Implant Diameter Ø3.75 and 4.2 mm Trade Name MIS Implant M4 & SEVEN Wide Platform Abutment Platform Diameter Ø5.0 and 6.0 mm Implant Diameter Ø5.0 and 6.0 mm | | | | K160626 | 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 | 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists 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. 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. Drawings included in reference device, K160626 correctly reflect the proposed abutment platform diameter information. Note: The Zirconia Abutments are not | Page 12 of 57 {18} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | Abutment to the endosseous implant. ATLANTIS™ products are compatible with the implants shown in the table below. Implant Manufacturer - HIOSSEN INC Trade Name HIOSSEN ET III SA Fixture Mini Abutment Platform Diameter Ø 3,5mm Implant Diameter Ø 3,5mm Trade Name HIOSSEN ET III SA Fixture Regular Abutment Platform Diameter Ø4.0, 4.5, 5.0, 6.0, 7.0 mm Implant Diameter Ø4.0, 4.5, 5.0, 6.0, 7.0 mm | 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: Hiossen Implant System: Hiossen ET III SA Fixture Implant Diameter (in mm): 3.5 (Mini), 4.0, 4.5, 5.0, 6.0, 7.0 (Regular) Abutment Platform Diameter (in mm): 2.797 (Mini), 3.350 (Regular) | proposed to be modified in this submission as this Bundled submission is limited to Atlantis Abutments in Titanium. | | K130999 | 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the 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 partially or completely edentulous patients. The prosthesis is screw retained. The abutment | 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 prostheses, 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists between the internal CAD software and the 3Shape software (K151455). Removed incorrect statement around “The prosthesis [crown] can be cemented, screw retained or friction fit to the abutment”. This was removed because a crown cannot be screwed/friction fitted to an abutment. Crowns are always cemented to an abutment. Similarly, removed “The prosthesis [crown] is screw retained” from the | Page 13 of 57 {19} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | screw is intended to secure the 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™ Abutment to the endosseous implant. ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV. | 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: AstraTech EV Implant Diameter (in mm): 3.0 ((XS) Green) Abutment Platform Diameter (in mm): 2.500 (XS) Implant System: PrimeTaper EV Implant Diameter (in mm): 3.0 ((XS) Green) Abutment Platform Diameter (in mm): 2.500 (XS) Implant System: OmniTaper EV | Crown Abutment indications. Added Healing Abutment indications. Specified the compatible implant diameter and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. Expanded compatibility with more recently cleared Dentsply Sirona EV implants, the PrimeTaper EV (K220841) and OmniTaper EV (K221094). Fatigue testing with the Atlantis Abutments was reviewed in these implant system reference device submissions. Note: The Zirconia Abutments are not proposed to be modified in this submission as this Bundled submission is limited to Atlantis Abutments in Titanium. | Page 14 of 57 {20} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | Implant Diameter (in mm): 3.0 ((XS) Green), Abutment Platform Diameter (in mm): 2.500 (XS) Implant System: AstraTech EV Profile Implant Diameter (in mm): 4.2, 4.8 Abutment Platform Diameter (in mm): 3.152 (4.2), 3.641 (4.8) | | | K111287 | Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. | 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 | The originally cleared abutments have the same internal connection geometry as the Atlantis abutments as they are compatible with the same EV implant system. Fatigue testing with these abutments was reviewed in the PrimeTaper EV implant system (K210610) and the Omnitaper EV implant system (K221094) submissions. The proposed Atlantis Abutments will have the same indications as the other Atlantis Abutments and specify the implant system, implant diameter, and abutment diameter. | Page 15 of 57 {21} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | 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: AstraTech EV Implant Diameter (in mm): 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8 ((L) Blue), 5.4 ((XL) Brown) Abutment Platform Diameter (in mm): 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) Implant System: PrimeTaper EV Implant Diameter (in mm): 3.6 ((S) Purple), 4.2 ((M) Yellow), 4.8, 5.4 ((L) Blue) Abutment Platform Diameter (in mm): 2.900 (S), 3.500 (M), 4.100 (L) Implant System: OmniTaper EV Implant Diameter (in mm): 3.4 ((S) Purple), 3.8 ((M) Yellow), 4.5 ((L) Blue), 5.5 ((XL) Brown) Abutment Platform Diameter (in mm): 2.900 (S), 3.500 (M), 4.100 (L), 4.600 (XL) | | | K101004 | The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely | Atlantis Abutment & Atlantis Abutment Milling The Atlantis Abutment and Atlantis Abutment | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to | Page 16 of 57 {22} | 510(k) | 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 or screw 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: The titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos 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. | 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. | demonstrate that the same design envelope exists 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, Conus Abutment, and Crown Abutment indications. This abutment is not offered as a Crown 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. 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. This is consistent with changes made in the predicate device, K250081. | Page 17 of 57 {23} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | Implant Manufacturer: Dentsply Sirona Implant System: Ankylos C/X Implant Diameter (in mm): 3.5, 4.5, 5.5, 7 Abutment Platform Diameter (in mm): 2.520 | Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. Expansion of Atlantis Abutment offering by adding a non-indexed version (“C/” version) Atlantis Abutment compatible with the same Dentsply Sirona Ankylos implant system. | | K093483 | 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 or screw 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: The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants. | 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists 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, Conus Abutment, and Crown Abutment indications. Specified the compatible implant diameter and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. Added compatibility with the Nobel Replace Conical Connection and NobelActive | Page 18 of 57 {24} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | 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: Nobel Active/Nobel Replace Conical Connection (NP, RP, WP) Implant Diameter (in mm): 3.5 (NP), 4.3, 5.0 (RP), 5.5 (WP) Abutment Platform Diameter (in mm): 2.939 (NP), 3.334 (RP), 4.389 (WP) | WP. Note: The Zirconia Abutments are not proposed to be modified in this submission as this Bundled submission is limited to Atlantis Abutments in Titanium. | | K083871 | 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: | 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cement retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. | Page 19 of 57 {25} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | The titanium abutments are compatible with the Straumann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm and the Straumann Narrow Neck 3.5mm The abutments in zirconia are compatible with the Straumann Implants: SLActive 4.1mm and 4.8mm. 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 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: Straumann Implant System: Bone Level Cross-Fit Implant Diameter (in mm): 3.3 (NC), 4.1, 4.8 (RC) Abutment Platform Diameter (in mm): 2.766 (NC), 3.295 (RC) Implant System: Standard Plus Implant Diameter (in mm): 3.3 (NN) Abutment Platform Diameter (in mm): 3.491 | 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. This is consistent with changes made in the predicate device, K250081. Added the abutment platform diameter information to be consistent with the more recent Atlantis Abutment clearances. The Narrow Neck implant has a 3.5 mm platform diameter but a 3.3 mm implant diameter. Therefore, the indications were updated to specify the implant diameter. Note: The Zirconia Abutments are not proposed to be modified in this submission as this Bundled submission is limited to Atlantis Abutments in Titanium. | Page 20 of 57 {26} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | K053654 | 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. This device is compatible with the following manufacturers' implant systems: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage. 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. | 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cement 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. 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. This is consistent with changes made in the predicate device, K250081. Many of the implant systems that were originally cleared are discontinued. The implant systems are consolidated as | Page 21 of 57 {27} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | 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: Nobel Replace (tri-channel connection) Implant Diameter (in mm): 3.5 (NP), 4.3 (RP), 5.0 (WP), 6.0 Abutment Platform Diameter (in mm): 3.53 (NP), 4.30 (RP), 5.00 (WP), 5.99 (6.0) | “NobelReplace (tri-channel connection)”. Specified the compatible implant diameter and abutment platform diameter to be consistent with the more recent Atlantis Abutment clearances. | | K053373 | 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. 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 umm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant. | 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 | Added Atlantis Abutment Milling to the Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cement retained to the abutment”. This was removed as this is redundant since crowns are always cemented to an abutment. 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 | Page 22 of 57 {28} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | 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: Zimmer Dental Implant System: Tapered Screw-Vent Implant Diameter (in mm): 3.7, 4.1, 4.7, 6.0 Abutment Platform Diameter (in mm): 3.536 (3.7, 4.1), 4.514 (4.7), 5.720 (6.0) Implant System: Tapered Screw-Vent (Friction Fit) Implant Diameter (in mm): 3.7, 4.1, 4.7, 6.0 Abutment Platform Diameter (in mm): 3.413 (3.7, 4.1), 4.385 (4.7), 5.612 (6.0) Implant System: Screw-Vent Implant Diameter (in mm): 3.7, 4.7 Abutment Platform Diameter (in mm): 3.536 (3.7), 4.514 (4.7) Implant System: Screw-Vent (Friction Fit) Implant Diameter (in mm): 3.7, 4.7 Abutment Platform Diameter (in mm): 3.413 (3.7), 4.385 (4.7) | Instructions for Use. This is consistent with changes made in the predicate device, K250081. 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. Expansion of Atlantis Abutment offering by adding a friction-fit version Atlantis Abutment compatible with the same Zimmer Dental implant system. | | K050052 | The Atlantis Abutment is intended for use as | Atlantis Abutment & Atlantis Abutment | Added Atlantis Abutment Milling to the | Page 23 of 57 {29} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | 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. | 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 | Atlantis Abutment indications. Software validation is included in the submission to demonstrate that the same design envelope exists between the internal CAD software and the 3Shape software (K151455). Removed the statement around “The prosthesis [crown] can be cement 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 24 of 57 {30} | 510(k) | Reference Device Indications for Use | Proposed Device Indications for Use | Discussion | | --- | --- | --- | --- | | | | screw is intended to secure the Atlantis Healing Abutment to the endosseous implant. Implant Manufacturer: Straumann Implant System: Standard/Standard Plus Implant Diameter (in mm): 3.3, 4.1, 4.8 (RN), 4.8 (WN) Abutment Platform Diameter (in mm): 4.771 (RN), 6.474 (WN) | | Page 25 of 57 {31} 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 indicate MR Conditional. The Abutments will be changed from MR Not Evaluated to MR Conditional which is consistent with the predicate device (K250081). 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 change in MR Conditional labeling, the submission also includes changes shared across the abutment family that were internally documented and therefore reflect the current version of the abutments, while some changes are new, generalizable changes requested to be cleared within this 510(k). Therefore, this submission proposes the same changes made in K250081 for a different group of Atlantis® Abutments in Titanium, with a few additional changes specific to this group of abutments. **Angulated Screw Access (ASA)** The Angulated Screw Access (ASA) feature is added to some Atlantis® Abutments, as cleared in the predicate device, K250081. 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** Atlantis® Healing Abutments, Conus Abutments, and Crown Abutments were added to some interfaces that were not originally cleared with this offering. This offering is already cleared in the predicate device, K250081. The additional abutments (Healing, Conus, and Crown) are within the design envelope of the corresponding cleared Atlantis® Abutment and have the same mating geometry to the implant, which has been tested per ISO 14801. **Expanded Compatibility and Abutment variants** The Atlantis® Abutments in Titanium were expanded to be compatible with additional implant systems with the same interface connections as originally cleared, to have larger size abutments compatible with existing implant system compatibilities, and to have new options (friction-fit/interference type, additional index positioning type) abutments compatible with the same implant systems. Where applicable, when the expansion has the potential to modify the worst-case construct for fatigue testing, comparative performance testing is included in the submission to support the expansion. **Modification to Abutment Dimensions** Modification to abutment dimensions was triggered by new metrology data, improved clearance between implant, abutment and screw, and more efficient manufacturability. Where applicable, when the change has the potential to modify the worst-case construct for fatigue testing, comparative performance testing is included in the submission to support the modification. Page 26 of 57 {32} Page 27 of 57 # Modification to Screws 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 predica…
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