FRIALIT-2 CYLINDER

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Friatec AG C/O Mr. Robert Joel Slomoff 9229 Cranford Drive Potomac, Maryland 20854 FEB 1 0 1998 Re : K974359 Frialit - 2 Cylinder Trade Name: Requlatory Class: III Product Code: DZE Dated: November 2, 1997 Received: November 19, 1997 Dear Mr. Slomoff: 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 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 be subject to such additional controls. Existing major regulations 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Slomoff through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or 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 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 requlation (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 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" (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.qov/cdrh/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}------------------------------------------------ Page_____ol 5 10(k) Number (if known): Pending Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: ## INDICATIONS FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Gencurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, and General Hos 510(k) Number Prescription Use Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ಉದ್ಯೋಕ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109) (Optional Format 1-2-9G)