DIAMOND D HIGH IMPACT DENTURE ACRYLIC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like symbol, which is the department's official logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 3 2003 Mr. Larry Steffier Mycone Dental Supply Company Incorporated 616 Hollywood Avenue Cherry Hill, New Jersey 08002 Re: K032773 Trade/Device Name: Diamond D High Implant Denture Material Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 5, 2003 Received: September 8, 2003 Dear Mr. Steffier: 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. {1}------------------------------------------------ Page 2 -Ms. Steffier 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. 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 (OS) 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 vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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, Simon Runne Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page_ of 510(k) Number (if known): K032773 Device Name: Diamond D High Impact Denture Material Indications For Use: Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients. M. Uphu for MSR (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K032773 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)