The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

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 restorations.

The Atlantis™ Abutments in Zirconia for BioHorizons Implant and abutment screws are made from biocompatible vttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

AI/ML Overview

The provided text is a 510(k) summary for a pre-market notification of a dental implant abutment. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document focuses on establishing substantial equivalence to a predicate device, as required for 510(k) submissions. This typically involves demonstrating that the new device has the same intended use, technological characteristics (materials, design), and performs similarly to a legally marketed device, often through a comparison of engineering specifications and materials rather than extensive clinical efficacy studies with specific performance metrics.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study to prove they are met from the provided input. The document explicitly states:

"The Atlantis™ Abutments in Zirconia for BioHorizons Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Zimmer Interface cleared under K053373 and BioHorizons Prodigy System™ Dental Implants cleared under K042429."

This highlights that the basis for approval is substantial equivalence, not a standalone study demonstrating performance against a set of predefined acceptance criteria for the new device itself.

To answer your specific points based on the absence of information:

A table of acceptance criteria and the reported device performance: This information is not provided in the document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or related performance data is described in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication is described.
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: This document pertains to a dental abutment, not an AI-assisted diagnostic tool, so an MRMC study is not relevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study requiring ground truth is described.
The sample size for the training set: Not applicable, as no algorithm training is described.
How the ground truth for the training set was established: Not applicable, as no algorithm training is described.

Summary

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FEB 2 9 2008

Pre-market Notification Page - 000009 - - - - - - - - - - - - - - - - - -

VII. SECTION 10 - 510(K) SUMMARY

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

1. Applicant's Name and Address

Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 Telephone Number: 617-871-2783 Fax Number: 617-871-6607 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

2. Name of Device

Trade Name:	Atlantis™ Abutment in Zirconia for BioHorizonsImplant
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment21 CFR 872.3630 Product code NHA

Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.

Manufacturer	Device	510(k)Number
Atlantis ComponentsInc.	AtlantisTM Abutment in Zirconia forZimmer Implant	K053450
BioHorizons ImplantSystems Inc.	The Prodigy SystemTM DentalImplants	K042429

4. Description of the Device

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Pre-market Page - 000010 - -------------------

4. Description of the Device (continued)

5. . Intended Use of the Device

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. 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.

6. Basis for Substantial Equivalence

The Atlantis™ Abutments in Zirconia for BioHorizons Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Zimmer Interface cleared under K053373 and BioHorizons Prodigy System™ Dental Implants cleared under K042429.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of several curved lines.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 9 2008

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

Re: K073540

Trade/Device Name: Atlantis™ Abutment in Zirconia for BioHorizons Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 11, 2007 Received: December 18, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snytte y. Michian Omd.

Chiu Lin, Ph.D. 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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Pre-market Notification Page - 000227

Indications for Use

510(k) Number (if Known) K07 3540

Device Name: Atlantis ™ Abutment in Zirconia for BioHorizons Implant

Indication for Use:

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.

Prescription Use X (Part 21 CFR 801 SubpartD) 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)

Susa
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073546

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.)