SELF CURE COMPOSITE

K991488 · Harry J. Bosworth Co. · EBF · Jun 21, 1999 · Dental

Device Facts

• Record ID: K991488
• Device Name: SELF CURE COMPOSITE
• Applicant: Harry J. Bosworth Co.
• Product Code: EBF · Dental
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The two paste system, when combined in approximately equal portions of universal and catalyst, will auto-polymerize to form a hard, radiopaque material for anterior restorations and core buildups.

Device Story

Self Cure Composite is a two-paste dental restorative system consisting of universal and catalyst components. When mixed in equal portions, the material undergoes auto-polymerization to form a hard, radiopaque restorative material. Used by dental professionals in clinical settings for anterior restorations and core buildups. The material provides a structural replacement for tooth tissue, aiding in the restoration of dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-paste system (universal and catalyst); auto-polymerizing chemistry; radiopaque restorative material.

Indications for Use

Indicated for patients requiring anterior dental restorations and core buildups.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue 60076 Skokie, Illinois

Re : K991488 Trade Name: Self Cure Composite Regulatory Class: II Product Code: EBF April 19, 1999 Dated: Received: April 28, 1999

Dear Ms. Goldstein:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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.

{1}------------------------------------------------

Page 2 - Ms. Goldstein

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] 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

{2}------------------------------------------------

Page 1 of 1

510(k) Number: K 991488

Device Name: SELF CURE COMPOSITE

INDICATIONS FOR USE:

The two paste system, when combined in approximately equal portions of universal and catalyst, will auto-polymerize to form a hard, radiopaque material for anterior restorations and core buildups.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Rumm

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