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{0}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 9 1999 Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228 Re : K990534 Trade Name: Excite Requlatory Class: I Product Code: KLE Dated: February 16, 1999 Received: February 19, 1999 Dear Mr. Mancuso: 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. ਉ 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 requlatory 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 {1}------------------------------------------------ Page 2 - Mr. Mancuso 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 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" (21CFR 807.97). Other general 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 A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K990534 Page 510(k) Number (if known): K990534 Device Name: ## Confidential Indications For Use: のお Excite adhesive is for use in clinical situations in which adhesion between light initiated resin based restorative or cementation materials and dentin and enamel is desired. - Adhesion of direct light initiated resin based restorations or repairs including: composite, ceromer and . compomer to enamel and dentin. - Adhesion of light initiated resin based cementation materials to enamel and dentin during final . placement of indirect restorations including: veneers, inlays, onlays, and single and multiple unit restorations. - As a resin based wetting agent to improve adhesion between silanated ceramic or ceromer surfaces . (indirect restorations, repairs) and light initiated resin cements and restoratives. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susar Runne `(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.` 0990534 ``` Prescription Use ✓ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)