TURKOM-CERA

{0}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 9 2006 Mr. Dan Watson Vice President Dental Suppliers of America, Incorporated 18616 123td Avenue, NE Arlington, Washington 98223 Re: K060860 Trade/Device Name: Turkom-Cera Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 10, 2006 Received: May 12, 2006 Dear Mr. Watson: 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 - Mr. Dan Watson Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of advised aller in a reservination that your device complies with other requirements of the Act or that I Dri has muce a actegulations administered by other Federal agencies. You must comply with all 1 coords statutes and 10 generaling, 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 iabeling (21 CFR Part 800); 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) I his lotter will and in your your finding of substantial equivalence of your device to a legally premarked notification - 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), please If you decire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general 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/industry/support/index.html. Sincerely yours, Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): Device Name: Turkom-Cera (Coping for porcelain teeth) ### Indications for Use: Turkom-Cera fused alumina copings are indicated for use as core structures of an artificial prosthesis, i.e., a three unit bridge, long bridges, full mouth bridges, for partially endentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The copings are also indicated for use as single crowns that will be cemented to a natural or an artificial tooth abutment in the treatment of partially endentulous patients in order to restore chewing function. Prescription Use × (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) unne Page 1 of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . an of Anasthesiology, General Hospits), on Control, Dantal Devices