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 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm diameters.

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

Also, 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 3i Certain Interface is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards (6972 & 13356). The abutment screw is made from Titanium grade Ti-6A1-4V ELI (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 3i Osseotite NT® Certain™ Implants (tapered wall) with 4.0 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) diameters.

AI/ML Overview

The provided text focuses on regulatory approval (510(k) submission) for a dental abutment. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, it does not contain information about specific performance acceptance criteria or a study that directly proves the device meets those criteria, as typically found in a clinical or performance study report.

The document states the device "meets ISO Standards (6972 & 13356)" for its material (yttria-stabilized tetragonal zirconia polycrystals - Y-TZP) and its abutment screw material "Meets ASTM Standard F-136" (Titanium grade Ti-6A1-4V ELI). These are material specifications, not performance criteria for the assembled device.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample size used for the test set and the data provenance: No performance testing data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment/expert review is mentioned as part of a performance study.
Adjudication method for the test set: Not applicable as no performance test data is provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a physical dental abutment, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance test data is provided.
The sample size for the training set: Not applicable as no AI/algorithm training is involved.
How the ground truth for the training set was established: Not applicable as no AI/algorithm training is involved.

The document is a regulatory submission demonstrating substantial equivalence, relying on the fact that the new device has similar materials, design, and intended use as devices already on the market, which are presumed to be safe and effective. It does not include a detailed performance study with acceptance criteria.

Summary

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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: 617-661-9799 Fax Number: 617-661-9063 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

2. Name of Device

Trade Name:	Atlantis™ Abutment in Zirconia for 3i CertainInterface
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.	Atlantis Abutment and AbutmentScrew	K981858
3i Implant Innovations	Osseotite NT Certain Dental Implants	K031475
Atlantis ComponentsInc.	Atlantis Abutment in Zirconia	K052070

4. Description of the Device

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4. Description of the Device (continued)

న్. 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 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: 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 the limited strength of the implant fixture.

6. Basis for Substantial Equivalence

The Atlantis™ Abutments in Zirconia for 3i Certain Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858, 3i Osseotite NT Certain Abutments cleared under K031475, and the Atlantis Abutment in Zirconia cleared under K052070.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 0 2 2007

Re: K063734

Trade/Device Name: Atlantis™ Abutment in Zirconia for 3i Certain Interface Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 18, 2006 Received: December 18, 2006

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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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 your 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 vours.

Supite Y. Michie DMD

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) KO6 37 34

Device Name: Atlantis ™ Abutment in Zirconia for 3i Certain Interface

Indication for Use:

This device is compatible with the 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm diameters.

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

Susan Roane

i Anashiostology, General Huspiral Comici, Cisital Devices

K063734

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)

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.)