ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT

K080164 · Zimmer Dental, Inc. · NHA · Sep 25, 2008 · Dental

Device Facts

• Record ID: K080164
• Device Name: ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer® Patient Specific 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 restoration in anterior and pre-molar regions.

Device Story

Zimmer® Patient-Specific Ceramic Abutment is a zirconia-based dental abutment; designed to support cemented prosthetic restorations. Device is custom-manufactured based on individual patient requirements to optimize functional and esthetic outcomes. Used by dental professionals in clinical settings to connect endosseous dental implants to prosthetic crowns or bridges. Provides structural support for restorations in anterior and pre-molar regions; facilitates patient-specific anatomical fit.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Zirconia. Form factor: Patient-specific custom abutment. Function: Endosseous dental implant abutment for cemented prostheses.

Indications for Use

Indicated for use as a terminal or intermediate abutment for cemented prostheses in single or multiple-unit restorations within anterior and pre-molar regions.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• ASTRA Tech, ZirDesign™ Ceramic Abutment

Submission Summary (Full Text)

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

Zimmer Dental

510k No.: K080164

Page No .: A5-1

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

SEP 2 5 2008

## Traditional 510(k) PRE-MARKET NOTIFICATION

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

1. Submitter's Information:

| Name: | Zimmer Dental Inc. |
|----------------|-------------------------|
| Address: | 1900 Aston Ave. |
| | Carlsbad, CA 92008-7308 |
| Phone: | 760-929-4300 |
| Contact: | Melissa Burbage |
| Date Prepared: | September 16, 2008 |

- 2. Device Name: Zimmer® Patient-Specific Ceramic Abutment
Device Classification Name: Endosseous Dental Implant Abutment

- Predicate Device: ASTRA Tech, ZirDesign™ Ceramic Abutment 3.
- 4. Device Description:

The Zimmer® Patient-Specific Ceramic Abutment is a zirconia abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration.

- 5. Intended Use:
The Zimmer® Patient Specific 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 restoration in anterior and pre-molar regions.

- 6. Device Comparison:
The new device is substantially equivalent to the predicate relative to material and general design features. In addition, the new device is substantially equivalent to the predicate as evidenced in mechanical testing.

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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 eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 5 2008

Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008

Rc: K080164

Trade/Device Name: Zimmer® Patient-Specific Ceramic Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 16, 2008 Received: September 19, 2008

Dear Ms. Burbage:

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. Burbage

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu 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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### Indications for Use

510(k) Number (if known):

K080164

#### Zimmer® Patient-Specific Ceramic Abutment Device Name:

Indications For Use:

The Zimmer Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for single or multipleunit restorations in anterior and pre-molar regions.

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 Rumores

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

510(k) Number: Kos0164

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