LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble an eagle or bird in flight. Public Health Service JAN 1 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mondeal Medical Systems GmbH C/O Ms. Angelika Scherp Director, Regulatory Affairs Business Support International Amstel 320-1 1017AP Amsterdam The Netherlands Re: K042345 Trade/Device Name: Lin/Liou Orthodontic Mini Anchor System (Lomas) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2004 Received: November 30, 2004 Dear Ms. Scherp: 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. Scherp Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advised and 22 a determination that your device complies with other requirements modifine Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouctial the Act's requirements, including, but not limited to: registration 1 ou intere comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 er read 001), eguality systems (QS) regulation (21 CFR Part 820); and if requirence as bet renis 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) Frider will and in Jo The FDA finding of substantial equivalence of your device to a premaince notification - 11 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), 11 you donto the Office of Compliance at (301) 594-0115. 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 may ovean 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, Clats 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 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ ## Device Name: LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) ## Indications for Use: The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only Prescription Use X (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) Susan Rapps (Division Sign-Off) ് (Division of Anesthesiology, General Hospital, Infection Control Dental Dental Devices 510(k) Number: Page 1 of 1