PROCERA IMPLANT BRIDGE ZIRCONIA

K053091 · Nobel Biocare AB · NHA · Jan 27, 2006 · Dental

Device Facts

• Record ID: K053091
• Device Name: PROCERA IMPLANT BRIDGE ZIRCONIA
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Jan 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Procera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems: Straumann Dental Implant System Regular Neck 4.8, Straumann Dental Implant System Wide Neck 6.5, 3i 3.75, Lifecore Biomedical Restore 3.75, Zimmer Dental Taper-Lock 4.0, Sterngold Implamed 3.75.

Device Story

Procera Implant Bridge Zirconia is a dental prosthetic framework milled from a single solid piece of zirconia (zirconium oxide). It features precision-milled interfaces for endosseous dental implants. The device is designed for 2 to 8 units and functions as a load-bearing framework for implant-anchored prosthetics. It is supplied as a semi-finished, non-sterile device to dental laboratories, where it undergoes veneering and completion before delivery to the clinician for patient placement. The device is intended to restore chewing function in edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Zirconia (zirconium oxide). Form factor: Milled bridge framework (2-8 units). Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Manufacturing: Precision milling.

Indications for Use

Indicated for patients with partially or totally edentulous jaws requiring restoration of chewing function via a bridge framework supported by dental implants.

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

• Procera Implant Bridge (K043042)
• Procera Implant Bridge (K041236)

Submission Summary (Full Text)

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K053091

## 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Phuong Nguyen Son<br>Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | November 2, 2005 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Procera® Implant Bridge Zirconia |
| Legally Marketed Device(s): | Procera® Implant Bridge (K043042)<br>Procera® Implant Bridge (K041236) |

## Device Description:

Procera® Implant Bridge Zirconia is a dental prosthetic framework milled from one solid piece of Zirconia (zirconium oxide). The many endosseous implant interfaces that can be used in the Procers" implant Bridge Zirconia are precision milled and are an integral part of the framework.

The Procera® Implant Bridge Zirconia can be precision milled for two (2) to eight (8) units. The bridge is to function as a load-bearing device for implant-anchored prosthetics.

The Procera® Implant Bridge Zirconia is a packaged as a semi-finished, non-sterile, device and delivered to the dental laboratory for veneering and completion. The final, veneered, Procera® Implomation and colle Zirconia is delivered from the dental laboratory to the clinician.

## Indications for Use:

The Procera® Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

In addition to Nobel Biocare implant systems, the Procera® Implant Bridge Zirconia can be used on the following implant systems:

- Straumann Dental Implant System Regular Neck 4.8 י
- Straumann Dental Implant System Wide Neck 6.5 "
- -31 3.75
- -Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0 -
- -Sterngold Implamed 3.75

Nobel Biocare USA Traditional 510(k) Notification Procera® Implant Bridge Zirconia November 2005

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JAN 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Mr. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K053091

Trade/Device Name: Procera Implant Bridge Zirconia Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 22, 2005 Received: November 23, 2005

Dear Mr. Nguyen Son:

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 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Nguyen Son

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

Sincerely yours.

Spatz y Michael Diaz.

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

KOS3091 510(k) Number (if known):

Device Name: Procera Implant Bridge Zirconia

Indications For Use:

The Procera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems:

- Straumann Dental Implant System Regular Neck 4.8
- Straumann Dental Implant System Wide Neck 6.5
- 31 3.75
- Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0
- Sterngold Implamed 3.75

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, _Office of Device Evaluation (ODE)

Susan Rumer

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