PROCERA BRIDGE ZIRCONIA by NOBEL BIOCARE AB

Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may consist of two to eights units and is cemented to natural or artificial tooth abutments.

Device Description

Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procerat Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

AI/ML Overview

The provided text is a 510(k) Summary for a dental device (Procera® Bridge Zirconia), which describes its intended use and regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt for proving the device meets acceptance criteria.

The document is a regulatory submission for a physical dental prosthesis, not a software algorithm, and therefore the concepts of "test set," "training set," "experts," "adjudication," "MRMC," or "standalone performance" as they relate to AI/software performance evaluation are not applicable here.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets these criteria based on the provided text.

Summary

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510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Phuong Nguyen SonRegulatory Affairs Specialist
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7830
Facsimile:	(714) 282-9023
Date of Submission:	November 4, 2005
Classification Name:	Porcelain Tooth (21 CFR 872.3920)
Trade or Proprietaryor Model Name:	Procera® Bridge Zirconia
Legally Marketed Device(s):	Procera® Bridge Zirconia (K041283)

Device Description:

Indications for Use:

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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 consists of a stylized caduceus symbol, which features three lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

Nobel Biocare AB C/O Ms. Phuong Nguyen Son Noble Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K053125

Trade/Device Name: Procera Bridge Zirconia Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2006 Received: February 13, 2006

Dear Ms. 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 ( vour 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 Eederal Register.

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Page 2 – Ms. Phuong Nguyen Son

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oc acressed that 1 DT 3 issuaires or that your device complies with other requirements mean that inde a december and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and reguirements, including, but not limited to: registration You must comply with an alle Her b rog 21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), laositis systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality bjovenie (Sections (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 This letter will anow you to oegal manting of substantial equivalence of your device 510(K) prematics nothreation: "Invice 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), If you desire specific at read to fyour as at (240) 276-0115. Also, please note the regulation prease contact the Other or Othernan premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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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K053125 510(k) Number (if known):

Device Name: Procera Bridge Zirconia

Indications For Use:

Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an rtificial prosthesis for partially edentulous patients in the need of prosthetic oral artifically proomoolo for parraity on the Procera Bridge Zirconia may roomstron in eration in eratis cemented to natural or artificial tooth abutments.

× 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 Punse

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a Anarth Mashingy, General Hospital in Connel, Dental Davice

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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.)