OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in bold, black letters. The word is encased in a black, oval shape that curves above and below the text. The font is sans-serif and appears to be a custom design to fit within the oval shape. K051798 7 2006 APR ## 510(k) Summary Device Proprietary Name: OsteoMed Orthodontic Anchor Plating System Device Common Name: Classification Name: DZE Implant, Endosseous, Root-Form Name of Submitter: OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601 Endosseous Implant Contact Person: Dawn D. Tindall Date Prepared: January 12, 2006 Summary: This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only. The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041651). Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed Orthodontic Anchor Plating System does not raise any new safety or effectiveness issues. Image /page/0/Picture/21 description: The image shows the logo for A Colson Associates. The logo features the word "Colson" in a stylized font, with the letters partially obscured by a dark circle. To the right of the circle, the words "A Colson Associates" are written in a bold, sans-serif font. The overall design is simple and professional. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile. The figures are arranged in a row, with their heads overlapping slightly. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 7 2006 Ms. Dawn T. Holderman Regulatory Affairs Osteomed, L.P. 3885 Arapaho Road Addison, Texas 75001 Re: K051798 Trade/Device Name: OsteoMed Orthodontic Anchor Plating System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: January 12, 2006 Received: January 17, 2006 Dear Ms. Holderman: 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. {2}------------------------------------------------ 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 (OS) 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. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Supt. y. Michael Davis Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _ Ko Sl 798 OsteoMed Orthodontic Anchor Plating System Device Name: Indications for Use: Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Posted November 13, 2003) Sver Rums " general Hospital Hospita J. Dental Devices KCS 1798 4000