MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines. MAR 3 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095 Re: K050730 K050730 Trade/Device Name: Orthodontic Composite Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Codes: DYW and DYH Dated: March 16, 2005 Received: March 21, 2005 Dear Ms. Lavery: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) pic.harket is substantially equivalent (for the indications for referenced above and have determined the devices marketed in interstate commerce use stated in the enclosure) to legally market of nealines marketed in interstate on to devic use stated in the enclosure) to legally hian keep preading Device Amendments, or to devices that prior to May 28, 1976, the enactilient date of the Median of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provisions of the Features (PM have been reclassified in accordance with the provisions of the Act. The Act. The may, Act (Act) that do not require approval of a premarket approval application of the gener Act (Act) that do not require approval or a promazions provisions of the Act. The general therefore, market the device, subject to the general contrologistican, listing of de therefore, market the device, subject to the general one ple registration, listing of devices, good controls provisions of the Act include requirements for annual registerati controls provisions of the Act mende requirements for and adulteration. 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 If your device is classified (See above) into Child Crass affecting your device can be may be subject to such additional controls. The 21 p. on addition FDA may publish may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may publish found in the Code of Federal resgments your device in the Federal Register. {1}------------------------------------------------ ## Page 2 -- Ms. Tammy Lavery Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issualice of a substance complies with requirements of the Act or that FDA has made a determination that your devel cases of our must comply with that FDA has made a defermination that your ac-hoo other Federal semies. You must comply with any Federal statutes and regulations administered by other Federal series (21 C any Federal statutes and regulations administered by other registration and listing (21 CFR Part 807); all the Act's requirements, including, but not limited to registration all the Act's requirements, including, but not innite att as set forth in the quality labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the labeling (21 CFR Part 801); good manufacturing production of the electronic product radiation systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21 CF (CF (CF (CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article as walness of your device to a legally premarket notification. The FDA finding of substantial equipalised this per premarket notification. The FDA midnig of substantial of the results in the spermits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please r the regulation and 11, 2011 and 11:55 at the regulation entitled If you desire specific advice for your active of the Also, please note the regulation entitled, a contact the Office of Compliance at (210) 210 of 10.197 Part 807.97). You may obtain other "Misbranding by reference to premarket notification" (21 CFR Part Bir in of Small "Misbranding by relerchec to premailer tional of the Act from the Division of Small general information on your responsibilities under the Act from the 1900 6 general information of your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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}------------------------------------------------ 510(k) Number (if known): Modification (Unknown) K050730 Device Name: Orthodontic Composite Bracket System Indications for Use: The Orthodontic Composite Bracket System is a self-ligating, orthodontic bracket unquely The Orthodonite Composite Dracter By Midhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109 Over-The-Counter Use ાર Prescription Use (Optional Format 1-2-96) . Asson Sign-Off) · ision of Anesthesiclogy, General Hospital, Claction Control, Dental Devices "(k) Number: