SOWELL PATENTED NON-PRECIOUS METAL ALLOY

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 8 1997 Ms. Anna Chin ·Distributor C.K. International Trading 2807 Holly Avenue Arcadia, California 91007 K973566 Re: Sowell Patented Non-Precious Metal Alloy Trade Name: Regulatory Class: II Product Code: EJH September 16, 1997 Dated: September 19, 1997 Received: Dear Ms. Chin: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Ms. Chin through 542 of the Act for devices under the Electronic Chrough 542 Of the Rec-101 covices as other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your station quivalence of your device to a legally marketed predicate device results in a classification for your markets predicals 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) 594-4618. Additionally, for questions on comprrance at (50) and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". sincerely yours, K. Allrust Timoth y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ _of_1 Page__________________________________________________________________________________________________________________________________________________________________________ K973566 510(k) Number (if known):_ Device Name: NON-PRECIOUS METAL ALLOY NON-PRECIOUS METAL ALLOY FOR CROWN, BRIDGE, Indications For Use: INLAYS, ONLAY, AND RESTORATION. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner (Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number. Prescription Use (Per 21 CFR 801.109) ાવ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)