BENCHMARK-IV

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 4 1997 Mr. Tridib Dasgupta Director R&D and Q.C. J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504 USA Re: K971575 Trade Name: Benchmark-IV Regulatory Class: II Product Code: EJT Dated: April 3, 1997 Received: April 7, 1997 Dear Mr. Dasgupta: 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 {1} Page 2 - Mr. Dasgupta premarket notification submission does not affect any obligation you might have under sections 531 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 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 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.gov/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} JELENKO DENTAL HEALTH PRODUCTS 150 900 REGISTERED 90 BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA (800) 431-1785 REQ 12-9-96; 9:40; 301 480 3002 => JELENKO; #3 2/09/96 MON 09:45 FAX 301 480 3002 FDA/ODE/DDIGD 003 Page 1 of 1 K971575 510(k) Number (if known): not available Device Name: Benchmark-IV Indications For Use: It is palladium free, rich gold colored, Type-IV extra hard alloy for Hard Inlays, Crowns, Fixed Bridgework. This High noble alloy offers strength, resiliency and hardness for hard inlays and longspan bridges. It resists tarnish and discoloration and can be quenched {Soft} and heat-treated {Hardened}. It can be used for restorative works. 2nd Sengupta (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runes (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K971575 Prescription Use VES (Per 21 CFR 801.109) OR Over-The-Counter Use NO (Optional Format 1-2-96)