HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

{0}------------------------------------------------ 4/29/99 Image /page/0/Picture/1 description: The image shows the words "510K SUMMARY" in large, bold letters at the top. Below that, there is a handwritten number "K991161". The text and number are centered on a white background. {1}------------------------------------------------ Date Prepared 04/06/99 Submitted by Clark Smith D.M.D. Kay-See Dental 124 East Missouri Avenue Kansas City, MO 64106 Telephone 800-842-8844 Fax 816-842-3204 : Contact Clark Smith D.M.D. Prepared by Barry Hale 7707 E 201 terr Belton, MO 64012 816-322-4641 {2}------------------------------------------------ Trade name - Hydro-Cast Acrylic Varnish Common name - Acrylic Varnish Classification Name - Resin, Denture, Relining, Repairing, Rebasing (872.3760) Substantial equivalence claimed to - PalaSeal K892452 Description of the device. Acrylic varnish. Intended use of device Is applied to cured materials such as dentures, partial dentures, dental splints, and temporary crowns/bridges for the purpose of sealing the acrylic surface. Page 3S {3}------------------------------------------------ ## TECHNOLOGICAL CHARACTERISIC COMPARISON PalaSeal Preparation of methyl methacrylate monomer, multifunctional methacrylates, light sensitizer, polymerization initiator. Hydro-Cast Acrylic Varnish Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization. Summary: The technological characteristics of the two devices are identical. Page 4S {4}------------------------------------------------ ## NON-CLINICAL TESTING AND DATA The testing of Hydro-Cast Acrylic Varnish was conducted using five randomly drawn subgroups, with three samples taken from each subgroup. The samples were applied to acrylic denture surfaces and the drying time observed. The specification for drying time is, dry to the touch in < 3 minutes. All samples were dry in less than 3 minutes. Page SS {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes intertwined around a central staff. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 9 1999 Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294 Re : K991161 Hydro-Cast Acrylic Varnish, Model 78125 Trade Name: Requlatory Class: I Product Code: EIA Dated: April 6, 1999 Received: April 7, 1999 Dear Dr. Smith: 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. ਰ 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 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. {6}------------------------------------------------ Page 2 - Dr. Smith This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production of mits 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 gener Other qeneral 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 {7}------------------------------------------------ ## STATEMENT OF INDICATIONS FOR USE Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface. crylic surface. Clark Smith D.M.D **Prescription Use** (Per 21 CFR 801.109) Susan Runno (Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices ુવ 1110 510(k) Number