AQUEOUS ACRYLIC DISPERSION 28% W/W

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "HUMAN SERVICES USA" and "DEPARTMENT OF" are arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 5 2002 Mr. Ross Perry President CHX Technologies, Incorporated 4800 Dundas Street West, Suite 105 Toronto, Ontario M9A 1B1 CANADA Re: K023671 Trade/Device Name: Prevora Stage 2 Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 30, 2002 Received: November 01, 2002 ## Dear Mr. Perry: 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}------------------------------------------------ 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. 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). 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, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number: # K023671 Device Name: Prevora Stage 2 Indications for Use: Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva. Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient. (Note: This indication for use is the same as approved device Chlorzoin Stage 2, #K944934). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | <div align="center">Susa Rump</div> | |----------------|-----------------------------------------------| | | (Division Sign-Off) | | | Division of Anesthesiology, General Hospital, | | | Infection Control, Dental Devices | | 510(k) Number: | K023671 | | Prescription Use | <div>✓</div> | OR | Over-the-Counter Use ________ | |----------------------|--------------|----|-------------------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |