ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 2000 Mr. Scott E. Moore Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Joardan, Utah 84095 Re: K994261 Trade Name: UltraTemp Temporary Polycarboxylate Cement Regulatory Class: II Product Code: EMA Dated: December 8, 1999 Received: December 17, 1999 Dear Mr. Manelli: 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. Exisping major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ನ್ 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 {1}------------------------------------------------ Page 2 - Mr. Manelli 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 Timo Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page_1_of_1 K994261 510(k) Number (if known): Unknown Device Name: _____________________________________________________________________________________________________ Indications For Use: UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) V Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use Susan Runyon (Optional Format 1-2-90 (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I !- 1 Q(k) Number