NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN

{0}------------------------------------------------ ## 510(k) SUMMARY 5) P.S. NAME & ADDRESS: K983966 DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax (777) 854-2942 P. J. Lehn Telefax (717) 849-4343 P. Jeffery Lehn CONTACT: DATE PREPARED: November 5, 1998 TRADE OR PROPRIETARY NAME: NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® Oral cavity abrasive polishing agent 872.6030 CLASSIFICATION NAME: K912945 PREDICATE DEVICES: NUPRO® Prophylaxis Paste with Fluoride DEVICE DESCRIPTION: NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures. The new device contains fluoride, triclosan®, an abrasive, a sweetener, water, flavoring, color, thickeners, and preservatives. INTENDED USE: : NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® is to be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. TECHNOLOGICAL CHARACTERISTICS: All of the components found in NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® have been used in the predicate device or been found to be safe for dental use. Triclosan is present in Colgate Total tooth paste at the same concentration used in NUPRO® PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN®. Studies concluded that triclosan is non-carcinogenic, non-mutagenic, is a non-irritant and a non-sensitizer. We believe that the prior use of the components of NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® in legally marketed predicate devices and an approved OTC tooth paste, the performance data, and the results of biocompatibility testing support the safety and effectiveness of NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® for the indicated uses. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle's head and neck, formed by three curved lines. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 29 1999 Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 K983966 Re : Nupro® Prophylaxis Paste with Fluoride and Trade Name: Triclosan® Requlatory Class: I Product Code: EJR Dated: November 5, 1998 Received: November 6, 1998 Dear Mr. Lehn: 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 aqainst 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 requlations 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) requlation (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. {2}------------------------------------------------ Page 2 - Mr. Lehn 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 {3}------------------------------------------------ ## PREMARKET NOTIFICATION ## INDICATIONS FOR USE STATEMENT (As Required by 21 CFR 801.109) 510(K) Number: Device Name: NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Susan Punner (Division Sign-Off) Division of Denes). Infection Control, and General Hospital Device 510(k) Number 0000009