BOSWORTH BOND

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and arms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 5 2005 Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076 Re: K043170 Trade/Device Name: Bosworth Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 17, 2005 Received: February 18, 2005 Dear Ms. Goldstein: 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 -- Ms. Mildred M. Goldstein Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA S Issualice of a substition with other requirements of the Act or that FDA nas made a determination mar your as a read to vother Federal agencies. You must comply with any Federal statures and regulations administered by 10: registration and listing (21 CFR Part 807); all the Act s requirements, including, but not interest requirements as set forth in the quality. Iabeling (21 CFR Part 801); good manufacturing practice requirements as set labeling (21 CFR Part 801), good manazation of applicable, the electronic product radiation Systems (QD) regarders 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) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nothication. "The IDA midning of backannal requence 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 If you desire specific advice 101 your as (240) 276-0115. Also, please note the regulation entitled, Comact the Office of Comphanes at (210) of CFR Part 807.97). You may obtain other Misoranting of reference to promaibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Clats 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 Enclosure {2}------------------------------------------------ Page 1 of 1 510(K) Number: _K043170 Device Name: Bosworth Bond ## INDICATIONS FOR USE: Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond. Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use (Optional Format 1/2/96) Siva Kumar Sian-Off Crision of Anesthesiology, General Hospital, Chection Control, Dental Devices Number: K043170