ZIMMER CONTOUR RESTORATIVE SYSTEM by ZIMMER DENTAL INC.

The Zimmer® Contour Healing Cap is for use with a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.

The Zimmer® Contour Provisional Coping is used for fabricating a cement-retained provisional restoration for a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional cap is not to exceed 28 days.

Device Description

The Zimmer Contour Restorative System is used to aid in the preparation of dental prostheses, as well as, to form the gingival tissue around an endosseous implant site prior to prosthesis fixation. The system is used with Zimmer Dental abutment-endosseous dental implant combinations, as well as, the Zimmer® One-Piece Implant. Devices are available in titanium or acrylic.

AI/ML Overview

This document is a 510(k) summary for the Zimmer® Contour Restorative System, specifically for the healing collar, healing cap, and provisional coping components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document discusses:

Device identification: Zimmer® Contour Restorative System (Healing Collar, Healing Cap, Provisional Coping).
Intended Use: Shaping gingival tissue (healing collar), preventing irritation and material lodging (healing cap), and fabricating provisional restorations (provisional coping).
Device Description: Used with Zimmer Dental abutment-endosseous dental implant combinations and Zimmer® One-Piece Implant, available in titanium or acrylic.
Predicate Devices: Zimmer Dental Advent® Implant Extender/Healing Collar, 3i EP Two Piece Healing Abutment, Lifecore Quick-Abutment Temporary/Healing Cap, Zimmer Dental Pure Form Ceramic Coping.
Substantial Equivalence: Zimmer Dental Inc. believes the device is substantially equivalent to its predicates in intended use, design, and materials.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo performance studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) process might.

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 large, bold letter "Z" inside. Below the circle, the word "zimmer" is written in a stylized font. Underneath "zimmer", the word "dental" is written in a smaller, simpler font.

Zimmer Dental

1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph)

510k No .:

Page No .: A5-1

JUN 2 7 2006

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

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:	April 12, 2006

Zimmer® Contour Restorative System Device Name:

Device Classification Name: Endosseous Dental Implant Abutment

1. Predicate Device(s):
- . Zimmer Dental Advent® Implant Extender/ Healing Collar
- . 3i EP Two Piece Healing Abutment
- Lifecore Quick-Abutment Temporary/ Healing Cap .
- Zimmer Dental Pure Form Ceramic Coping .
1. Device Description:

ട്. Intended Use:
The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.

Device Comparison: 6.
Zimmer Dental Inc. believes the Zimmer® Contour Healing Collar. Healing Cap and Provisional Coping to be substantially equivalent to their respective predicates. They are equivalent in intended use, design, and materials.

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Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 2006

Mr. Eric L. McVev Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K061043

Trade/Device Name: Zimmer® Contour Restorative System Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 12, 2006 Reccived: June 15, 2006

Dear Mr. McVey:

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 H (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. McVey

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 cntitled, "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.

Clare

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):

Device Name: Zimmer® Contour Healing Collar Zimmer® Contour Healing Cap Zimmer® Contour Provisional Coping

Indications For Use:

The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis.

The Zimmer® Contour Healing Cap is for use with a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due a more against the restorative area of the abutment or implant, and to prevent materials from lodging in any undercuts or openings.

The Zimmer® Contour Provisional Coping is used for fabricating a cement one neg provisional restoration for a Hex-Lock™ Contour Abutment or a Zimment of College Implant. Use of the provisional coping is not to exceed 28 days.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Union ... .. (21 CFR 801 Subpart C :

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER FOR A NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sunil Kumar

13 hasiology, General Hospital, n Continel, Dental Devic

K061043

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.)