SILCAST (CODE NAME RD-0118)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its head and wings, creating a sense of movement and dynamism. The overall design is simple and professional, reflecting the department's role in public health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 1 1998 Mr. Tridib Dasgupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504 K981247 Re : SILCAST (Code Name RD-0118) Trade Name: Regulatory Class: II Product Code: ETS Dated: April 2, 1998 Received: April 6, 1998 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 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). 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 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 regulation 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. Dasgupta through 542 of the Act for devices under the Electronic Product Radiation 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 the Office of Compliance at (301) 594-4639. Also, please note 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 R. Ulatowski 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 PRUD **JELENKO** J. F. F. JELENKO & CO. DENTAL HESS PARK DAIVE. ARMONK. NEW YOHK U.S.A. 10504 + (814) 273 - 860 1 Page / of / 510(k) Number (if known): K 981247 Device Name: SILCAST [Code Name: RD-0118] Indications For Use: SII CAST ( RD-0118 ) is a predominently base metal alloy under ADA and er Type-March (2000) and arters for Dental alloy, It is designed for Type-III SII CAST ( RD-0118 ) is a predominently base included tor Treehard Crown and Bridge alloy. hard Crown and Bridge alloy. SILCAST with platinum-white color provides quality restorations and it SILCAST with platinum-white color provides quality itstore.com . SILCAST with platinum-white color provides quality itsubres. polishes to a high lusture. This bace in and short span bridges. Zridis Angri 6/25/98 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Beatrice Shuman (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) YES OR Over-The-Counter Use