The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely endentulous 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 and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

The Atlantis™ Crown Abutment in Zirconia 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 screw is intended to secure the crown abutment to the endosseous implant.

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

the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 of the mouth 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 titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized 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

This document describes a 510(k) premarket notification for the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant. This is a medical device submission, and therefore, the information provided is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This equivalence is primarily shown through comparisons of technological characteristics, intended use, and performance characteristics. The acceptance criteria aren't explicitly numerical thresholds as one might see for a diagnostic AI.

Here's a table based on the provided "Substantial Equivalence Summary" (Table 1):

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Atlantis™ Abutment & Crown Abutment in Zirconia)
Material	- Titanium Alloy (Keystone Genesis Implant System K#101545)	- Titanium Alloy
	- Biocompatible ceramic material (Astra Tech's Atlantis™ Crown Abutment in Zirconia K#110356)	- Biocompatible ceramic material (Zirconia: yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) meeting ISO Standards 6972 & 13356))
Performance Characteristics	Allows prosthesis to be cemented or screw retained to abutment. Abutment screw secures abutment to implant. (Both predicates)	Allows the prosthesis to be cemented or screw retained to abutment. Abutment screw is intended to secure the abutment to the endosseous implant. (For Zirconia Crown Abutment, prosthesis is screw retained and abutment screw secures the crown abutment to the endosseous implant.)
Intended Use	- Support prosthetic device in partially/completely edentulous patients.	- Titanium & zirconia abutments: Support prosthetic device in partially/completely edentulous patients (single/multiple tooth prosthesis, mandible/maxilla).
	- Support single or multiple tooth prosthesis, in mandible or maxilla.	- Zirconia Crown Abutment: Function as a substructure and final restoration in partially/completely edentulous patients (single/multiple tooth prosthesis, mandible/maxilla). Prosthesis is screw retained; abutment screw secures crown abutment.
	- For crown abutments: Function as substructure and final restoration, screw retained.
Mechanical Stability	Implied equivalent to predicate devices through static and fatigue testing.	"Test results demonstrated that the Atlantis Abutments are compatible with the Keystone Genesis implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended."

2. Sample size used for the test set and the data provenance

Sample Size: The document mentions "worst case scenario" implant assemblies were tested, but it does not specify the numerical sample size used for the static and fatigue compression testing.
Data Provenance: The testing was conducted as part of the premarket submission by Astra Tech Inc. It is internal testing to demonstrate the device's compatibility and performance. The document does not specify the country of origin of the data further than implying it's internal to the manufacturer's R&D process. It is prospective data generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the context of this 510(k) submission. For medical devices like dental abutments, "ground truth" is typically established through direct physical and mechanical testing (e.g., material properties, static and fatigue strength) against engineering standards and comparison to predicate devices, rather than expert consensus on observational data.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate cases (e.g., medical images) and their interpretations need to be reconciled. This submission focuses on physical performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human performance with and without AI assistance is being compared. The device in question is a physical dental abutment, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance evaluation of an algorithm was not done. This device is a physical product, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of the Atlantis™ Abutment and Atlantis™ Crown Abutment is established through physical and mechanical testing (static and fatigue compression testing) designed to simulate the in-vivo environment and demonstrate that the device performs as intended and is comparable to previously cleared predicate devices. The "truth" is based on meeting engineering specifications and demonstrating mechanical integrity under specified loads.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of developing and validating a physical dental abutment. Training sets are used for machine learning algorithms.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reason as in point 8.

Summary

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K.113003

Premarket Notification Section 5: Page - 4

510(k) Summary

Astra Tech Inc. Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02541 Telephone: 781-810-6462 Fax: 781-810-6719

Official Contact:

Representative/Consultant:

Betsy A. Brown

Franklin Uyleman

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

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:

Common Name:

Product Code: Classification Panel: Reviewing Branch:

Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis 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

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

The titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

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

the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 of the mouth 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 and the Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant are substantially equivalent in indications and design principles to Keystone's Genesis Implant System cleared under K#101545 and Astra Tech's Crown Abutment cleared

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Premarket Notification Section 5: Page – 6

under K#110356, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

TechnologicalCharacteristics	Atlantis™ Abutmentand CrownAbutment in Zirconiafor Keystone GenesisImplant	Keystone GenesisImplant SystemK#101545	Astra Tech'sAtlantis™ CrownAbutment inZirconiaK#110356
Material	-Titanium Alloy-Biocompatibleceramic material	-Titanium Alloy	Titanium Alloy-Biocompatibleceramic material
Performancecharacteristics	Allows the prosthesisto be cemented orscrew retained toabutment. While theabutment screw isintended to secure theabutment to theendosseous implant.	Allows the prosthesisto be cemented orscrew retained toabutment. While theabutment screw isintended to secure theabutment to theendosseous implant.	Allows theprosthesis to bescrew retained toabutment.
Intended Use	Titanium & zirconiaabutments:Intended for use withan endosseous implantto support a prostheticdevice in a partially orcompletelyendentulous patient.Intended for use tosupport single ormultiple toothprosthesis, in mandibleor maxilla.Zirconia CrownAbutment: Intendedfor use with anendosseus implant tofunction as asubstructure that alsoserves as the finalrestoration, in apartially or completely	Intended for use withan endosseous implantto support a prostheticdevice in a partially orcompletelyendentulous patient.Intended for use tosupport single ormultiple toothprosthesis, in mandibleor maxilla.	Intended for usewith an endosseousimplant to functionas a substructurethat also serves asthe finalrestoration, in apartially orcompletelyedentulous patient.It is intended tosupport single andmultiple toothprosthesis, in themandible ormaxilla. Theprosthesis is screwretained. Theabutment screw isintended to securethe crown abutmentto the endosseousimplant.
edentulous patient. It isintended to supportsingle and multipletooth prosthesis, in themandible or maxilla.The prosthesis is screwretained. The abutmentscrew is intended tosecure the crownabutment to theendosseous implant.

Table 1: Substantial Equivalence Summary

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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 Keystone Genesis implant. Test results demonstrated that the Atlantis Abutments are compatible with the Keystone Genesis implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the left side of the logo.

Public Health Service

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

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

MAR - 1 2012

Re: K113003

Trade/Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 20, 2012

Received: February 22, 2012

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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Page 2 - Ms. Brown

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.

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

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Premarket Notification Section 4: Page - 3

Indications for Use

510(k) Number (if known)

Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant

Indication for Use:

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

The titanium and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

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

the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 of the mouth 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 (O)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices .

510(k) Number: K113003

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.)