STERISIL ANTIMICROBIAL TUBING AND BOTTLE

{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 caduceus symbol, which is a staff with a serpent entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the caduceus. The logo is black and white. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 3 0 2003 Mr. Brad Downs Senior Vice President Sterisil 200 South Wilcox #417 Castle Rock, Colorado 80104 Re: K031681 Trade/Device Name: Sterisil® Antimicrobial Tubing and Bottle Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 02, 2003 Received: October 03, 2003 Dear Mr. Downs: 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. {1}------------------------------------------------ ## Page 2 - Mr. Brad Downs 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. In particular, please note that many water treatment products, such as your device, are also regulated by the Environmental Protection Agency's (EPA) Office of Pesticide Programs. You may wish to consult with EPA to determine if registration with the agency is necessary for your device. Regarding FDA, 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, Chin S. Lin, Ph.D. 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for "Sierisil." The logo consists of a stylized water droplet on the left, with a sunburst pattern inside. To the right of the droplet is the word "Sierisil" in a stylized font. The overall impression is clean and modern. ## 22, Indications for Use 510(k) Number (if known): K031681 Device Name: Dental Operative Unit Antimicrobial Bottle and Tubing Indications for Use: "The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water." Susan Bonner (Division Sign Division of Ane Liesiology, General Hospital Infection Contri, De 510(k) Number: (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)