Temphase temporary crown and bridge material is a two component, catalyst and base, material dispensed and mixed by a cartridge/static mixing tip combination. Temphase is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Temphase contains methacrylate components and is radiopaque for easy radiographic identification.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, "Temphase," a temporary crown and bridge restorative material. The submission focuses on demonstrating substantial equivalence to a predicate device, not on specific performance criteria or a study proving those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document is a regulatory approval letter and a summary of safety and effectiveness for a medical device. It attests that the device is substantially equivalent to existing products, thereby allowing it to be marketed. It does not contain the detailed study results or performance data that would typically be required to answer the questions posed.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.

Image /page/0/Picture/1 description: The image contains a sequence of handwritten characters and numbers. The sequence reads 'KO20092'. The characters are written in a cursive style, with some connections between the letters and numbers.

SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

FEB 2 2 2002

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: January 2002

Device Name:

Trade Name -- Temphase .
Common Name Temporary Dental Restorative Material .
Classification Name -- Temporary Crown and Bridge Resin. per 21 CFR § 872.3770 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, TempFil C&B .

Device Description:

Intended Use of the Device:

The intended use of Temphase is to be used to fabricate temporary crowns and bridges.

Substantial Equivalence:

Temphase is substantially equivalent to other legally marketed devices in the United States. Temphase functions in a manner similar to and is intended for the same use as the original TempFil C&B formulation that was manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867

Re: K020092

Trade/Device Name: Temphase Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: January 07, 2002 Received: January 10, 2002

Dear Ms. Boswell:

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.

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.

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Page 2 - Ms. Colleen Boswell

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF R Part 807), and 11 (QS) regulation (21 CFR Part 820); and if requirements as bet form in orduct 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 310(K) prematics notification with 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 up of CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally = CF (301) 594-4613. Additionally, for questions on the promotion and Office of Compliance in e, please contact the Office of Compliance at (301) 594-4639. also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21 CF N 2 a From the Division of Small Manufacturers, International and the Act may on over its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulstowski

Timothy Jlatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant:	Kerr Dental Materials Center
510(k) Number (if known):	K020092
Device Name:	Temphase

Indications For Use:
Temphase is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

Susan Runne

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

510(k) Number	K020092
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.