WILLI GELLER CREATION PORCELAIN

{0}------------------------------------------------ K98/490 ## SUMMARY OF DATA Willi Geller Creation porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations including porcelain fused to metal crowns and bridges, laminate veneers, and inlays. The product is substantially equivalent to the Willi Geller Creation ceramic which was cleared via 510(k) #K900209. The ceramic powders in the Creation porcelain system are composed in varying proportions of silicon dioxide, aluminum oxide, sodium oxide, potassium oxide, barium oxide, and iron oxide. Chemically stable mixed metal oxides, including spinel, baddeleyit, zircon, and periclase phases of zirconium, iron, cobalt, chromium, yttrium, cerium, nickel, and zinc oxides, are used in trace amounts for pigmentation. The paste opaques are comprised of ceramic powder fitting this description suspended in glycerol, zinc chloride, sodium acetate, propandiol, and aerosil. The stains are composed of silicon dioxide, aluminum oxide, tin oxide, tin oxide, barium oxide, iron oxide, and calcium oxide, and chemically stable mixed metal oxides for pigmentation. The modeling liquid is composed of zinc chloride and water. The shoulder liquid is composed of tylose and water. The glaze liquid is composed of methylethylene glycol and water. The opaque liquid is composed of zinc chloride, water, and sodium chloride. The vehicle used in the paste opaques and the liquids are evaporated during use, and are not incorporated into devices manufactured with the porcelain. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. OCT 2 2 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John M. Slanski Research and Development JENSEN Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473 K981490 Re: Willi Geller Creation Porcelain Trade Name: Regulatory Class: II Product Code: EIH Dated: July 27, 1998 Received: August 6, 1998 Dear Mr. Slanski: 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 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 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 Reqister. Please note: this response to your 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. {2}------------------------------------------------ Paqe 2 - Mr. Slanski 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) 594-4692. 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, Patricia Cucenta // Soc Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known):___Not_known Willi Geller Ceramic Porcelain Device Name: Indications For Use: The product is intended for use in fabricating oral crowns and bridges and laminate veneers and inlays for dental use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Herald Shreves (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1490 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use 5 પંચ (Optional Format 1-2-96)