(78 days)
CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.
CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the device "CompCore™ AF."
The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any study details or performance data as requested in your prompt.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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
Page 3-1
§ 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.