ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT by ZIMMER DENTAL INC.

The Zimmer® Angled Contour Zirconia Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration in anterior and pre-molar regions.

Device Description

The new Abutments have sa prepared margin and cone. The Abutments feature a pre-defined offset margin that is lower on the buccal aspect and higher on the lingual aspect to minimize the need to further prepare the Abutment by user. The cone portion of the Abutment is set at a 17 degree andle.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, specifically the Zimmer® Angled Contour Zirconia Abutment. It details device modifications and its substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, meaning the new device is as safe and effective as the predicate. It often relies on comparisons of design, materials, intended use, and performance data from internal testing to ensure the modified device functions similarly and poses no new risks. Without explicit performance criteria and a study demonstrating their achievement, it's impossible to fill in the requested table and answer the study-related questions.

Therefore, since the provided text does not contain the information requested, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies.

Summary

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<083474

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Image /page/0/Picture/2 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 serif font, with a line underneath it. Below the line, the word "dental" is written in a smaller, sans-serif font.

1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

Zimmer Denta

510k No.:
Page No.:	12.9

DEC 2 3 2008

Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k) 510(k) SUMMARY (21CFR807.92(a))

Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	William Fisher
Date Prepared:	November 19, 2008

1. Device Name: Zimmer Angled Contour Zirconia Abutment (cat no. ZRA351A, ZRA352A, ZRA461A, ZRA462A)
  Device Classification Name: Endosseous Dental Implant aBUTMENT
റ്റ് Predicate Device(s): Zimmer Patient Specific Abutment, Internal Hex, Ceramic
র্বা Device Description:

ട. Intended Use:

1. Device Comparison:
  The new device is equivalent in design with Predicate. The new device is a dimensional modification to the Predicate. It differs from the Predicate in that the cone portion of the new device is at a 17 degree angle, while the Patient Specific is angled per customer requirements. The materials, general structure, and function in the endosseous implant system remains the same as the Predicate Device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC 2 3 2008

Re: K083474

Trade/Device Name: Zimmer® Angled Contour Zirconia Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 20, 2008 Received: November 24, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chu S. Lin, Ph.D.

hiu S. Lin. Ph. D Division 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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Zimmer Dental

510(k) No. K083474

Attachment 12.13 1 of 1

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Indications for Use

510(k) Number (if known): __

Device Name: Zimmer® Angled Contour Zirconia Abutment

Indications For Use:

X Prescription Use (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)

Qve

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

510(k) Number: K083474

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.)