VECTORS TEMPORARY ANCHORAGE SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. The logo is black and white. K061230 AUG - 3 2006 ## Section III - 510(k) Summary of Safety and Effectiveness ### Submitter: Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: May 2006 #### Device Name: - . Trade Name - Vectors Temporary Anchorage System - Common Name Orthodontic Implant Screw . - Classification Name Implant, Endosseous Dental, per 21 CFR § 872.3640 . ### Devices for Which Substantial Equivalence is Claimed: - Medicon eG. Aarhus Anchorage System . - Dentaurum, Tomas Pin . - Imtec Corporation, Ortho Implant ● - Mondeal Medical Systems, Lomas Quattro . ### Device Description: The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation. ### Intended Use of the Device: The Vectors Temporary Anchorage System is intended to serve as 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. The screw is sterile and is intended for single use only. {1}------------------------------------------------ ## Substantial Equivalence: The Vectors Temporary Anchorage System is substantially equivalent to other legally marketed devices in the United States. The Vectors Temporary Anchorage System is composed of the same material and is substantially equivalent in application and function to the Aarhus Anchorage System Screws, Tomas Pin, Ortho Implant and Lomas Quattro marketed by Medicon eG, Dentaurum, Imtec Corporation and Mondeal Medical Systems, respectively. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 3 2007 Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660-8915 Re: K061230 Trade/Device Name: Vectors Temporary Anchorage System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: July 26, 2006 Received: July 27, 2006 Dear Ms. Boswell: This letter corrects our substantially equivalent letter of August 3, 2006. 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 (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 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. {3}------------------------------------------------ ## Page 2 - Ms. Boswell 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 continue 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 (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours. Chiu S. Lin, PhD 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Vectors Temporary Anchorage System Indications for Use: The Vectors Temporary Anchorage System is a threaded titanium dental implant screw 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. The screw is sterile and is intended for single use only. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susa Raser Gion Sign-Off) on of Anesthesiology, General Hospital, mion Control, Dental Devices Number: 1062530 Page 1 of 1