AIRDENT RADIANCE CURING LIGHT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with wavy lines below them. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 24 1998 Mr. Joseph Carey Director of Quality Assurance Air Techniques, Incorporated 70 Cantiaque Rock Road P.O. Box 870 Hicksville, New York 11801 Re : K982615 AirDent "Radiance" Curing Light Trade Name: Requlatory Class: II Product Code: EBZ Dated: July 22, 1998 Received: July 27, 1998 Dear Mr. Carey: 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 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 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 {1}------------------------------------------------ Page 2 - Mr. Carey 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, S. Butman for 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}------------------------------------------------ Page of | 510(k) Number (if known): | K982615 | |---------------------------|---------------------------------| | Device Name: | AirDent "RADIANCE" Curing Light | Indications For Use: The AirDent "Radiance" Curing Light is indicated for use in curing dental composite resin materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used. (PLEASE DO NOT WILTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBOD Concurence of CDRH, Office of Device Evaluation (ODE) Suan Russey (Division Sign Ciri Division of Dental, Infortes, Control, and General Hospital De ين يوت ૮૫૪ 510(k) Number . **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) 8661/6Z/L0 ទទួះទ្បា zo 30449 ้นี้ 9 ระบรมที่ 1 ใ