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: 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter 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.

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 MicroMini Implant is made of biocompatible material, yttria-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 the 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study data:

Based on the provided text, this document is a 510(k) summary for a dental abutment, not a study report for a novel AI/software device. Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance of an algorithm is not applicable or cannot be extracted from this type of document.

The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not typically to present detailed performance studies against specific acceptance criteria in the manner one would for a new diagnostic or AI-powered solution.

Here's what can be inferred or explicitly stated from the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or software device, nor does it report device performance against such metrics. The "performance" mentioned relates to the physical and material characteristics of the abutment, demonstrating equivalence to predicates.

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

Not Applicable. No "test set" in the context of an AI/software performance study is mentioned. The submission is about a physical dental abutment.

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

Not Applicable. Ground truth, in the context of an AI/software study, is not established or discussed here for a test set.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods are not relevant to this submission.

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

Not Applicable. No MRMC study was conducted or is mentioned, as this is a physical medical device, not an AI/software diagnostic tool requiring human reader improvement assessments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical abutment, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. "Ground truth" in the context of performance evaluation for an AI model is not applicable here. The "ground truth" for this device would relate to its physical and material properties meeting established standards and being equivalent to predicates.

8. The Sample Size for the Training Set

Not Applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not Applicable. No training set, no ground truth establishment for a training set.

Summary of Relevant Information from the Provided Text:

The document describes a dental abutment and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Device: Atlantis™ Abutment in Zirconia for 3i Certain MicroMini Implant.
Intended Use: To provide support for a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained.
Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment, titanium grade Ti-6Al-V ELI for the screws.
Standards Met: ISO Standards 6972 & 13356 for the Y-TZP material, ASTM Standard F-136 for the titanium screws.
Basis for Equivalence: Intended use, material, design, and performance are substantially equivalent to predicate devices: K062069, K063734 (both Atlantis Abutments), and K014235 (3i Certain Implant System).

The "performance" aspect is demonstrated by the device's compatibility with existing implant systems and its material properties meeting specified ISO and ASTM standards, which are implicitly the "acceptance criteria" for its physical characteristics and safety/effectiveness in the context of substantial equivalence. This differs significantly from the performance metrics and studies typically associated with AI/software medical devices.

Summary

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Pre-market Notification Page - 00009 - - - - - - - - - - - - - - -

NOV 1 6 2007

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.

l. 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 CertainMicroMini Implant
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 for 3i CertainMicroMini	K062069
Atlantis ComponentsInc.	Atlantis Abutment in Zirconia for 3iMicroMini	K063734
3i Implant Innovations	3i Certain Implant System	K014235

4. Description of the Device

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Pre-market Page - 00010 - - - - - - - - - - - - - - - -

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 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 MicroMini Implant are

substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for 3i Certain MicroMini Implant cleared under K062069, the Atlantis Abutment in Zirconia 3i Certain MicroMini Implant cleared under K063734 and for the 3i Certain Implant System cleared under K014235.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

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

Re: K072483

Trade/Device Name: Atlantis™ Abutment in Zirconia for 3i Certain MicroMini Implants Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 22, 2007 Received: September 4, 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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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,

Neil R. Oglin
Chiu Lin, Ph.D.

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) KD72483

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

Indication for Use:

This device is compatible with the following manufacturers' implant systems: 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter 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.

Susan Roars

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

510(k) Number:

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.)