PROCERA BRIDGE ALUMINA by NOBEL BIOCARE AB

Nobel Biocare's Procera Bridge Alumina 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 Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.

Device Description

Nobel Biocare's Procera® Bridge Alumina 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 Procera® Bridge Alumina may be two, three, or four units and is precision milled. The Procera Bridge Alumina can be cemented or bonded to either natural or artificial tooth abutments. It is personalized according to the specific dimensions of the patient's so the bridge precisely fits, and properly functions, in the patient's jaw.

Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).

AI/ML Overview

The provided text describes a medical device, the Nobel Biocare Procera® Bridge Alumina, and its regulatory clearance (510(k)). However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a 510(k) summary and the corresponding FDA clearance letter. These documents confirm that the device is substantially equivalent to a predicate device and is cleared for marketing. They specify the device's description, indications for use, and regulatory classification but do not include details about performance studies used to demonstrate safety and effectiveness for a new device submission or a comparative effectiveness study.

Therefore, I cannot provide the requested information from the given text.

To be clear:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance: This information is not present in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided text.
4. Adjudication method: This information is not present in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present in the provided text. The device is a physical dental bridge, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is a physical dental bridge, not an algorithm.
7. The type of ground truth used: This information is not present in the provided text.
8. The sample size for the training set: This information is not present in the provided text.
9. How the ground truth for the training set was established: This information is not present in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K053050'. The characters are written in a bold, somewhat irregular style, giving them a distinct, hand-drawn appearance. The contrast between the characters and the background is high, making the sequence easily readable.

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:	October 26, 2005
Classification Name:	Porcelain Tooth (21 CFR 872.3920)
Trade or Proprietaryor Model Name:	Procera® Bridge Alumina
Legally Marketed Device(s):	Procera® Bridge Zirconia (K041283)

Device Description:

Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).

Indications for Use:

Nobel Biocare's Procera® Bridge Alumina 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 Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.

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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 three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

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

Re: K053050

Trade/Device Name: Procera Bridge Alumina Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 10, 2006 Received: February 13, 2006

Dear Mr. 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include econorements 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 Eederal Register.

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Page 2 - Mr. Son

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be advisod that 127 to testainst on that your device complies with other requirements modi that I Dri nas made waters and regulations administered by other Federal agencies. of the Act of any I outeral based is requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR rat 807), availity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon 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) This letter will and in J . The FDA finding of substantial equivalence of your device to a premarket notification. The PDF 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 the not no no no at (240) 276-0115. Also, please note the regulation prease contact the Online reference to 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih-Lin, Ph.D.

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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KOS3050 510(k) Number (if known):

Device Name: Procera Bridge Alumina

Indications For Use:

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)

Susa Quaser

technology, General Hosp.
and Dental Devices

K05 3050

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.)