BLUEWAND LED DENTAL CURING WAND SYSTEM

{0}------------------------------------------------ APR = 7 2004 # 510 (k) SUMMARY CONTACT: Larry L. Blosser DATE®PREPARED: January 22, 2004 TRADE OR PROPRIETARY NAME: BlueWand™ Dental Curing Wand System CLASSIFICATION NAME: visible light cure for polymerization PREDICATE DEVICES: L.E. Demetron 1 K021797 #### DEVICE DESCRIPTION: The BlueWand™ LED Dental Curing Light is a cordless battery-powered unit designed for curing visible light cured (VLC) materials whose initiators are sensitive to light in the 440-480 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation. The BlueWand™ LED Dental Curing Light System includes: - Surgical stainless steel handpiece with an LED and control electronics with . rechargeable battery - Transformer to supply wall power to the base unit ● - Base unit- charges battery and stores handpiece when not in use . The BlueWand™ has 6 standard curing modes, consisting of 10, 20 and 30 second durations, and operational from two settings: Manual Setting and Automatic Setting. ("Touch less - ON" function). The Modes are10s, 20s, and 30s, a ramp, and two "30% reduced power" modes for 20s and 30s. #### INTENDED USE: Curing camphorquinone-based visible light cured (VLC) materials ## TECHNOLOGICAL CHARACTERISTICS The BlueWand™ LED Dental Curing Light System is substantially equivalent to K021797 in intended use, operation, including the range of light emitted, curing time, and cooling. {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 eagle with three stripes representing health, human services, and prevention. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR = 7 2004 Mr. Larry L. Blosser President J.L. Blosser, Incorporated 22 North Main Liberty, Missouri 64068 Re: K040614 Trade/Device Name: BlueWand™ LED Curing Wand System Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 22, 2004 Received: March 11, 2004 Dear Mr. Blosser: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2 - Mr. Larry L. Blosser Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. sHiil Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040614 Device Name: BlueWand™ LED Dental Curing Wand System Indications for Use: The BlueWand™ LED Dental Curing Wand System is a cordless light intended for polymerization of visible light cured materials containing camphorquinone. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert S. Bert, DDS for Dr. S. Kummer v. General Hospit Page 1 of __ 1 510(k) Number: K040614