ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S by ZIMMER DENTAL INC.

The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.

Device Description

The Zimmer® Contour Ceramic Abutment is an abutment designed for use with endosseous dental implants to support single or multi tooth restorations. The abutment has a contoured emergence profile to create a more esthetic restoration. The abutment features a pre-machined margin to facilitate the restoration process. The abutment portion is composed of zirconia ceramic with a titanium alloy seating ring and separate titanium alloy screw for retention.

AI/ML Overview

This document is a 510(k) premarket notification for the Zimmer® Contour Ceramic Abutment and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria. As such, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader multi-case studies is largely not present in the provided text.

The document indicates that the device is deemed "substantially equivalent" to predicate devices based on design, intended use, mechanical strength, and materials. This equivalency is the basis for its clearance, not a performance study against specific acceptance criteria as you've outlined.

However, I can extract what is available about the device and its comparison:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific quantitative performance acceptance criteria in a study. The comparison is qualitative and based on device characteristics, not detailed performance metrics from a study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. This document does not describe a performance study with a test set of data.

3. 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):

This information is not provided. No ground truth establishment by experts is mentioned, as there is no described performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. No adjudication method is mentioned, as there is no described performance study.

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:

This information is not provided. This device is a dental abutment, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This information is not provided. This device is a physical dental implant component, not an algorithm.

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

This information is not provided. No ground truth is established for a performance study. The "truth" in this submission is the equivalency to already marketed devices.

8. The sample size for the training set:

This information is not provided. This document does not describe a study involving a training set.

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

This information is not provided. No ground truth for a training set is established.

Summary based on the provided document:

The supplied document is a 510(k) summary for the Zimmer® Contour Ceramic Abutment. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving performance against specific acceptance criteria.

The key points from the document are:

Device: Zimmer® Contour Ceramic Abutment
Intended Use: Terminal or intermediate abutment for a cemented prosthesis, for single or multiple-unit implant-supported restorations.
Materials: Zirconia ceramic abutment with a titanium alloy seating ring and separate titanium alloy screw.
Predicate Devices: ASTRATech ZirDesign™ Ceramic Abutment and Zimmer® Hex-Lock Abutment.
Basis for Clearance: Substantial equivalence in intended use, design, mechanical strength, and materials to the predicate devices.
No performance study against specific acceptance criteria is described in this document. The FDA's clearance is based on the comparison to predicate devices, implying that if the predicates are safe and effective, and this device is substantially equivalent, then it is also safe and effective.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized letter Z inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, lighter font.

Zimmer Dental
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1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph)

KO61847 510k No .:

A5-1

Page No .:

510(k) SUMMARY (21CFR807.92(a))

OCT 1 2 2006

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Erin L. McVey
Date Prepared:	June 29, 2006

1. Device Name: Zimmer® Contour Ceramic Abutment
- Device Classification Name: Endosseous Dental Implant Abutment
1. Predicate Device(s):
- . ASTRATech ZirDesign™ Ceramic Abutment (Cat. No. 24183)
- Zimmer® Hex-Lock Abutment (Cat. No. HLA3/3) .
Device Description: 4.

1. Intended Use:
  The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.
1. Device Comparison:
  Zimmer Dental Inc. believes the Zimmer® Contour Ceramic Abutment to be substantially equivalent to the predicates. They are equivalent in intended use, design, mechanical strength, and materials.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2006

Mr. William Fisher Zimmer Dental, Incorporated Regulatory Affairs Associate 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K061847

Trade/Device Name: Zimmer® Contour Ceramic Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 2, 2006 Received: October 3, 2006

Dear Mr. Fisher:

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 - Mr. Fisher

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 yours.

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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Indications for Use

510(k) Number (if known): _KOOL847

Zimmer® Contour Ceramic Abutment Device Name:

Indications For Use:

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 (ODE)

Susan Runor

Clon Sian-Off I Trision of Anesthesiology. General Hospital, Intection Control, Dental Device

Number: 2061847

Page 1 of 1 Page: Section A4-1

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.)