(78 days)
Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental desensitizer device. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.
The letter focuses on:
- Confirming that the device and its indications for use are substantially equivalent to a legally marketed predicate device.
- Outlining the regulatory requirements the manufacturer must comply with (e.g., registration, labeling, good manufacturing practice).
- Providing contact information for regulatory questions.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert qualifications from this document. This kind of information would typically be found in the 510(k) premarket notification submission itself, not in the clearance letter.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2002
Mr. Rolando Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618
Re: K013970
Trade/Device Name: Prime-Dent Hema Desensitizer Regulation Number: 872.3260 Regulation Name: Sealant Regulatory Class: II Product Code: LBH Dated: November 28, 2001 Received: December 3, 2001
Dear :
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. Marasigan
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 (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 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 21 CFR Part 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 Part 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,
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
Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth Prime-Dent® Hema Desensitizer is used or Delitise to other Desensitizer is also
cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also cavity preparation of sensitive root surfaces. I stillings and composites.
used as a wetting agent prior to bonding resin fillings and composites.
Susan Rungen
(Sivision Sign-Off) ുംഗ്ലോസ Sign-Off)
അമ്മ of Dental, Infection Control, ാന ന് Dental, Devices
Coneral Hospital Devices a mber ----
§ 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.