PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL by PRIME DENTAL MANUFACTURING, INC.

Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.

Device Description

Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The text is a letter from the FDA regarding a 510(k) premarket notification for a dental restorative material, Prime-Dent Chemical Cure Composite. It discusses regulatory matters and indications for use but does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

(JAN 3 1 2000

Mr. Rolando Marasigan V.P. of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618

Re : K994224 Prime-Dent Chemical Cure Composite Trade Name: Restorative Material Regulatory Class: II Product Code: EBF/KLE Dated: December 13 1999 Received: December 15, 1999

Dear Mr. Marasigan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Marasigan

obligation you might have under sections 531 through 542 of obligation you might have ahability of the Electronic Product Radiation the Act for devices ander on Federal laws or regulations.

This letter will allow you to begin marketing your device as first receir wire 510 k) premarket notification. The FDA described in your sie in promote of your device to a legally Linding of subblancial equired in a classification for your marketed predicate device bus device to proceed to the market.

If you desire specific advice for your device on our labeling II you debite opeonial additionally 809.10 for in regulation (stic devices), please contact the Office of Villo draghobere at (301) 594-4692. Additionally, for questions on Compriation and advertising of your device, please contact the Dffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance obtained from the bryibion or back-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
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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Indications for Use

escription Deville

Susan Vanre

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.