HILUX LEDMAX 3

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and prevention. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 4 2004 Mr. David G. Small Secretary of First Medica First Medical Infection Control Associates, Incorporated 3704-C Boren Drive Greensboro, North Carolina 27407 Re: K040956 Trade/Device Name: Hilux LEDMAX-3 Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 7, 2004 Received: May 3, 2004 Dear Mr. Small: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becausermined 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 merstate commerce prior to train ave been reclassified in accordance with the provisions of Amendinents, or to do roos and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Coou may, therefore, market the device, subject to the general approvial applicans of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 MA), it may of subject to fact and and Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South views announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 -Mr. Small Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a sabstance ice complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of any rederal statutes and regarations, but not limited to: registration You must comply with an the rice s req 21 CFR Part 801); good manufacturing practice. and ifsung (21 CFR Fart 807), labeling (21 CFR Part 87) 777 - FFR Part 820); and if fequirements as set form in the quality bjections (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) This letter will anow you to begin mainerally . premarket notification. The FDA finding of substantial equivalence of your device to a premiarket notification. The PDF mixers 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), If you desire specific advice to: your de at (301) 594-4613. 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 from the Inay obtain other general miremational and Consumer Assistance at its toll-free Driston of 0101638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Anthony D. ms for Shi-Jie, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use KO 40956 610(k) Number (if Known): Device Name: Hilux LEDMAX-3 Indications for Use: This curing light is used to cure or set camphorquinone initiated materials used in the dental industry including composites, sealants and cements. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart Ci (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Rumm (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: 16040956 Page 1 of