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 abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.

The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 on small diameter implants are intended for the anterior region only.

Device Description

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Camlog Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm. 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes. In addition. the Atlantis™ Abutment for Camlog Implant for the 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document implicitly defines acceptance criteria through the successful performance of "worst case scenario" implant assemblies under static and fatigue compression testing. The overarching acceptance criterion is that the implant system (Atlantis Abutments with Camlog implants) must perform as intended under these loads. "As intended" implies demonstrating mechanical integrity and stability comparable to or better than the predicate devices.

Reported Device Performance:

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Static Compression Testing	Must withstand appropriate static test loads. Demonstrate mechanical integrity.	Test results demonstrated that the implant system supported appropriate static test loads.
Fatigue Compression Testing	Must withstand appropriate fatigue test loads. Maintain structural integrity over time.	Test results demonstrated that the implant system supported appropriate fatigue test loads.
Compatibility	Must be compatible with Camlog implants.	Test results demonstrated that the Atlantis Abutments are compatible with the Camlog implants.
Overall Performance	Must perform as intended in supporting a prosthetic device under various loading conditions.	Test results demonstrated that the implant system performs as intended (implying it meets the functional and structural requirements for supporting prosthetic devices in an oral environment).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the exact number of samples (implant assemblies) used for static and fatigue compression testing. It refers to "worst case scenario" implant assemblies without specifying the quantity.
Data Provenance: This was a non-clinical bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective human data is not applicable. The tests were conducted to evaluate the mechanical performance of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This was a non-clinical bench testing study assessing mechanical performance against engineering standards and established methods for dental implant testing (static and fatigue compression). Ground truth was established through validated testing protocols and measurements, not expert human assessment.

4. Adjudication Method

Not Applicable. As this was a non-clinical bench testing study, there was no need for human adjudication of results. The outcomes are objective measurements of mechanical load bearing and fatigue resistance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating human reader performance with and without AI assistance, typically in image interpretation or diagnostic tasks. This submission is for a dental implant abutment, and the testing involved mechanical performance, not diagnostic review.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, in essence. The testing described is a "standalone" evaluation of the device's mechanical performance in a laboratory setting. The "device" here is the Atlantis™ Abutment and its interaction with the Camlog implant system. The performance evaluated (static and fatigue strength) is inherent to the device itself, without human intervention during the actual performance measurement. There is no "algorithm" in the context of an AI device.

7. The Type of Ground Truth Used

Engineering Standards and Bench Test Results: The "ground truth" for this device's performance is established by its ability to meet accepted industry standards for static and fatigue strength of dental implant components. The test results (load sustained, cycles to failure) serve as the objective ground truth, demonstrating the device's mechanical properties. It's not pathology, expert consensus, or outcomes data in the biological sense, but rather a mechanical performance assessment.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical medical device (dental implant abutment), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an algorithm, this question is not relevant to this device's submission.

Summary

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K110640

JUN 1 0 2011

Premarket Notification Section 5: Page - 4

510(k) Summary

Astra Tech Inc. Atlantis™ Abutment for Camlog Implant

ADMINISTRATIVE INFORMATION

510K Summary preparation date:	Februaury 1, 2011
Manufacturer Name:	Astra Tech Inc.590 Lincoln StreetWaltham, Massachusetts 02541
Telephone:	781-810-6462
Fax:	781-810-6719
Official Contact:	Franklin Uyleman
Representative/Consultant:	Betsy A. Brown

Betsy A. Brown B.A. Brown and Associates Inc. Telephone: 847-560-4406 847-677-0177 Fax:

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Product Code: Classification Panel: Reviewing Branch:

Atlantis™ Abutment for Camlog Implant Endosseous dental implant abutment 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

INTENDED USE

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Premarket Notification Section 5: Page - 5

INTENDED USE (continued)

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.

The zirconia abutments are compatible with the Camlog 3.8mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 on small diameter implants are intended for the anterior region only.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment for Camlog Implant is substantially equivalent in indications and design principles to Altatec GmbH predicate devices: Screwline Implant cleared under K022425. Cylinder Implant cleared under K000065 and Rootform Implant cleared under K000100 each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Premarket Notification Section 5: Page - 6

TechnologicalCharacteristics	Atlantis™ Abutment forCamlog Implant	Altatec Screwline,Cylinderand Rootform Implants
Material	-Titanium Alloy-Biocompatible ceramicmaterial	-Titanium Alloy
Performance characteristics	Allows the prosthesis to becemented or screw retained toabutment. While the abutmentscrew is intended to secure theabutment to the endosseousimplant.	Allows the prosthesis to becemented or screw retained toabutment. While the abutmentscrew is intended to secure theabutment to the endosseousimplant.
Intended Use	Intended for use with anendosseous implant to supporta prosthetic device in apartially or completelyendentulous patient. Intendedfor use to support single ormultiple tooth prosthesis, inmandible or maxilla.	Intended for use with anendosseous implant to supporta prosthetic device in apartially or completelyendentulous patient. Intendedfor use to support single ormultiple tooth prosthesis, inmandible or maxilla.

Table 1: Substantial Equivalence Summary

Summary of Non-clinical Testing

Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Camlog implants. Test results demonstrated that the Atlantis Abutments are compatible with the Camlog implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

Conclusion for Substantial Equivalence:

The Atlantis™ Abutment for Camlog Implant is substantially equivalent to Altatec's predicate devices: : Screwline Implant cleared under K022425, Cylinder Implant cleared under K000065 and Rootform Implant cleared under K000100, based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected, flowing lines, possibly representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 0 2011

Astra Tech. Incorporated C/ O Ms. Betsy A. Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K110640

Trade/Device Name: AtlantisTM Abutment for Camlog Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 3, 2011 Received: June 8, 2011

Dear Ms. Brown:

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 (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. 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Section 4: Page - 3

Indications for Use

510(k) Number (if known)_

Device Name: Atlantis™ Abutment for Camlog Implant

Indication for Use:

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.

The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 on small diameter implants are intended for the anterior region only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number:

(Division Sigm-Uff) Division of Anesthesiology, General Hospital infection Control, Dental Devices

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)