BIOFREE

K033925 · Dental Components, Inc. · EIA · Apr 7, 2004 · Dental

Device Facts

• Record ID: K033925
• Device Name: BIOFREE
• Applicant: Dental Components, Inc.
• Product Code: EIA · Dental
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

BIOFREE INHIBITS AND CONTROLS THE GROWTH OF BACTERIA, BIOFILM, ENDOTOXINS, FUNGUS, AND ALGAE PROVIDING ANTIMICROBIAL SURFACE IS REGENERATED WITH THE CONTINUOUS USE OF A STERISIL WATER PRE-TREATMENT PRODUCT. BIOFREE 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.

Device Story

Bio-Free Tubing and Bottle for Dental Operative Unit; antimicrobial components for dental water delivery systems. Device inhibits microbial growth (bacteria, biofilm, fungus, algae) on internal surfaces. Antimicrobial surface properties are regenerated via continuous use of Sterisil water pre-treatment product. Used in dental clinics; operated by dental staff. Provides antimicrobial environment for water delivery; reduces microbial contamination risk in dental procedures. Benefits patient by minimizing exposure to waterborne pathogens during dental treatment.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Antimicrobial tubing and bottle system for dental operative units. Designed for use with distilled, deionized, or reverse osmosis water. Regenerative antimicrobial surface technology activated by Sterisil water pre-treatment. Class I device, Product Code EIA.

Indications for Use

Indicated for use in dental operative units to inhibit and control bacterial, biofilm, endotoxin, fungal, and algal growth on internal tubing and bottle surfaces. Intended for use with distilled, deionized, or reverse osmosis water. Not for use with tap water. Not intended to provide sterile water.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

{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 [phone]. 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 [phone] or [phone] 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.