CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN

{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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 5 1998 Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road 03824-0799 Durham, New Hampshire Re : K981000 Carrara Porcelain and Carrara Vincent Trade Name: Porcelain Requlatory Class: II Product Code: EIH March 16, 1998 Dated: Received: March 18, 1998 Dear Mr. Everngam: 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 leqally 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). 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of-Federal Requlations, Title 21, Parts 800 to 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Mr. Everngam through 542 of the Act for devices under the Electronic emrough Sadiation Control provisions, or other Federal laws or requlations. 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. 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 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 {2}------------------------------------------------ 510(k) Premarket Notification for Carrara and Carrara Vincent Dental Porcelain. Submitted by european dental imports, inc., Reg#1218814 INDICATIONS FOR USE: | 510(K) Number: | K9810000 | |----------------|----------| |----------------|----------| Carrara Porcelain and Carrara Vincent Device Name: Porcelain Indications for Use: Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist. (Please do not write below this line) ============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation Prescription Use 241 - 11:42 = (Per 21 CFR 801.109) OR Over the Counter Use ----- Susa Rumpos on of Dental, Infection Control, neral Hosn