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 following manufacturers' implant systems: Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova and BioHorizons.

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.

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™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).

AI/ML Overview

This submission focuses on a dental implant abutment, specifically the Atlantis™ Abutment in Zirconia, and its substantial equivalence to previously marketed devices. The document does not describe a study involving a device with acceptance criteria and reported device performance in the context of an AI/software device. Instead, it is a 510(k) pre-market notification for a physical medical device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. The document is for a physical dental device, not a software or AI-driven diagnostic or treatment device.

However, I can extract the relevant information about the device itself and its deemed equivalence:

Device Description and Equivalence:

Device Name: Atlantis™ Abutment in Zirconia (Trade Name), Endosseous dental implant abutment (Common Name and Classification Name).
Intended Use: To be placed into a dental implant to provide support for a prosthetic reconstruction in a partially or completely edentulous patient. It supports single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment. The abutment screw secures the abutment to the endosseous implant.
Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment (Meets ISO standards 6872 & 13356), and Titanium grade Ti-6A1-4V ELI for the abutment screw (Meets ASTM Standard F-136).
Predicate Devices:
- Zimmer Dental, Screw Vent Implant System (K011028)
- Atlantis Components Inc., Atlantis Abutment in Zirconia (K052070)
Basis for Substantial Equivalence: The Atlantis™ Abutment in Zirconia is considered substantially equivalent in intended use, material, design, and performance to the listed predicate devices.
Compatibility: This device is compatible with implant systems from Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova, and BioHorizons.

Regarding the specific questions, and why they are not applicable here:

A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for substantial equivalence, not a performance study report for an AI or diagnostic device. There are no "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, AUC) for a physical abutment in this context. The acceptance is based on meeting the defined "Intended Use" and demonstrating equivalence in "material, design and performance" to predicate devices, which is generally done through mechanical testing and material characterization, not clinical performance metrics presented in a table like this.
Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of data as would be used for an AI/software device.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/software evaluation (e.g., expert labels for images) is not relevant for a physical dental abutment’s 510(k) submission.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. MRMC studies are for evaluating diagnostic accuracy, not for a physical implant component.
If a standalone performance was done: Not applicable in the context of AI. The "performance" assessment for this physical device would involve things like fatigue testing, biocompatibility, and fit, which are demonstrated to be equivalent to predicates rather than a standalone performance metric reported here.
The type of ground truth used: Not applicable. For a physical device like this, the "ground truth" for regulatory clearance is that it meets engineering specifications and is equivalent to previously cleared devices.
The sample size for the training set: Not applicable. No "training set" for a physical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission for a physical dental implant component, not a software or AI-driven device. Therefore, the questions designed to probe the evaluation of an AI-driven device are largely not relevant to this document.

Summary

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MAR 3 2006

Pre-market Notification Page - 0000009 ---------------------------

Kos 3450

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.

I . 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:	AtlantisTM Abutment in Zirconia
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
	21 CFR 872.3630 Product code NHA

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

Manufacturer	Device	510(k) Number
Zimmer Dental	Screw Vent Implant System	K011028
Atlantis ComponentsInc.	Atlantis Abutment in Zirconia	K052070

4. Description of the Device

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

ধ Description of the Device (continued)

ഗ് 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.

র্ত Basis for Substantial Equivalence

The Atlantis™ Abutment in Zirconia is substantially equivalent in intended use, material, design and performance to the Zimmer Screw Vent Implant System (K011028) and Atlantis Components Inc. Abutment in Zirconia (K052070).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3

2006

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

Re: K053450

Trade/Device Name: Atlantis™ Abutment for Zimmer Interface Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: February 10, 2006 Received: February 13, 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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Page 2 - Ms. Betsy A. 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 (OS) 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 yours.

Snytie y. Michael Dms.

Chiú 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) Kos 3450

Device Name: Atlantis TM Abutment for Zimmer Interface

Indication for Use:

This device is compatible with the following manufacturers' implant systems: Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova and BioHorizons.

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)

Signature:	Sina Rury
Concurrence of CDRH, Office of Device Evaluation (ODE)

gy General Hospi

K0534156

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.)