BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855

{0}------------------------------------------------ ## 5. 510(K) SUMMARY APR 2 1 2006 ## MONITEX INDUSTRIAL CO., LTD. Models: Blue Luxcer, Curing Light M-830, M-835, M-855 510K: ● Submitted by: MONITEX INDUSTRIAL CO., LTD. 6F, No.70, Guang-Fu Road, Sec. 1, San-Chung City, Taipei Hsien, 24158, Taiwan ● Official Correspondent: Mr. Shu-Lung, Wang General Management ● 510K Contact person: Dr. Jen, Ke-Min No.58, Fu-Chiun Street, Hsin Chu City, 30067, Taiwan Tel: 886-3-5208829 Fax: 886-3-5209783 Email: ceirs.jen@msa.hinet.net . Classification name: ACTIVATOR, ULTRAVIOLET, for POLYMERIZATION Classification number: ● EBZ, Class II Regulation Number: ● 872.6070 ● Proprietary name: Blue Luxcer, Curing Light M-830, M-835, M-855 . Common name of device: CURING LIGHT . Predicate Device: APOZA ENTERPRISE CO., LTD. LA500 Blue Light 510K No - K033201 {1}------------------------------------------------ Statement of Intended Use: Blue Luxcer, Curing Light M-830, M-835, M-855 The intended use of the Blue Luxcer, Curing Light is a visible curing unit programmed for the polymerization of light cure material by dental professionals. Comparison to Predicate Devices: The Blue Luxcer, Curing Light M-830, M-835, M-855, have been carefully compared to legally marketed devices with respect to intended use and characteristics. technological In addition. performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and are safe and effective in its intended use. We believe that the Blue Luxcer, Curing Light M-830. M-835, M-855 are substantially equivalent to the predicate device, i.e., APOZA CURING LIGHT, LA500 Blue Light in K033201, and the data provided support the safety and effectiveness for the intended uses. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES - USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arn 2 1 2006 Monitex Industrial Company, LTD C/O Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin Chu City, 30067 TAIWAN REPUBLIC OF CHINA Re: K060646 Trade/Device Name: Blue Luxcer Curing Light Models M-830, M-835, and M-855 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 06, 2006 Received: March 10, 2006 Dear Dr. Jen: 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 indicecons 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 in micrisate in micrisate committers 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. Trougheral 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 an 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. {3}------------------------------------------------ Page 2 - Dr. Ke-Min Jen 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html. Sincerely yours. Sruthi K. Mikkilineni 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 {4}------------------------------------------------ # 4. INDICATIONS FOR USE STATEMENT #### Indications for Use 11 660646 510(k) Number: Device Name: MONITEX INDUSTRIAL CO., LTD. Blue Luxcer, Curing Light M-830, M-835, M-855 ● Indications for use: This Blue Luxcer, Curing Light is a visible curing unit programmed for polymerization of light cured materials by dental professionals. | Prescription Use | √ | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | AND/OR | Over-The-Counter Use | | |------------------------|--| | (21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | . General H | |--|-------------| | | ...S | | | K060646 |