BIOFREE

{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 stylized eagle head with three horizontal lines extending from the back of the head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. APR - 7 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Richard W. Hanson Official Correspondent Dental Components, Incorporated 305 North Springbrook Road P.O. Box 228 NewBerg, Oregon 97132-0228 Re: K033925 Trade/Device Name: Bio-Free Tubing and Bottle for Dental Operative Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 19, 2004 Received: March 23, 2004 Dear Mr. Hanson: 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Hanson 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. 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 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, 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 K033925 510(k) Number (if known): గుట BIO -FREE TUBING AND BOTTLE FOR DENTAL GREATIVE Device Name: Indications For Use: BIOFREE " NHIGHTS AND CONTROLS THE GROWTH OF BACTERIA, BIOFIUM, ENDOTOXINS, FUNGUS, AND ALGAE PROVIDING ANTIMICROBIAL SURFACE IS REGENERATED WITH THE THE CONTINUOUS USE OF A STERISIL WATER PRE. TREATIMAT PRODUCT . BIOFREE IS INTENDED TO BE USED WITH DISTILLERS, DELOWIZED, OSMOSIS WATER. EFFICACY FOR TAP WATER HAS NOT OR REVERSE DETERMINED , THIS PRODUCT IS NOT INTENDED TO PANING ਤਿੰਦਾ ਹੈ। STERILE WATER. Prescription Use _ Ì (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) Robert Burton for Dr. S. Sumner Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number Page 1 of Image /page/2/Picture/13 description: The image shows the text "PAGE A-2" in a handwritten style. The word "PAGE" is written in all capital letters, followed by the letter "A", a hyphen, and the number "2". The text appears to be a page or section marker within a larger document.