COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

K012160 · Premier Dental Products Co. · EBF · Sep 27, 2001 · Dental

Device Facts

• Record ID: K012160
• Device Name: COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
• Applicant: Premier Dental Products Co.
• Product Code: EBF · Dental
• Decision Date: Sep 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

Device Story

CompCore™ AF is a fluoride-releasing resin composite material used for direct core build-ups in dental procedures. It is supplied as an automix system, facilitating consistent mixing and application by dental professionals in a clinical setting. The material is applied directly to the tooth structure to reconstruct missing tooth substance prior to crown placement. By providing a stable foundation, it supports restorative outcomes and benefits patients by restoring tooth function and structural integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Automix resin composite material; fluoride-releasing; dental restorative material; Class II; Product Code EBF; 21 CFR 872.2690.

Indications for Use

Indicated for direct fabrication of core build-ups in patients requiring dental restorative procedures.

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)

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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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2001

Premier Dental Products Company C/O Mr. Barry Hale Barry Hale C.Q.E. 7707 East 201 Terr Belton, Missouri 64012

Re: K012160

Trade/Device Name: CompCore™ AF Regulation Number: 872.2690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 11, 2001 Received: September 18, 2001

Dear Mr. Hale:

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 - Mr. Hale

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

K. Callatant

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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## KO12160

## Statement of Indications for Use

510(k) Number (If known) _ KO/ 乙/ 60

Device Name: CompCore™ AF

Indications for use: CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

Please do not write below this line 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 Runner

(Division Sign-Off) (Division Sign-on)
Division of Dental, Infection Control, and General Hospital Device E1 S010 F1 Click Number 510(k) Number ــ

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