TEMPORARY TOOTH REPLACEMENT

{0}------------------------------------------------ K081900 sds ### SYBRON DENTAL SPECIALTIES OCT 2 4 2008 Section III - 510(k) Summary of Safety and Effectiveness #### Submitter: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person Date Summary Prepared: July 2008 ## Device Name: - Trade Name Temporary Tooth Replacement (TTR) . - . Common Name - Temporary Endosseous Dental Implant - . Classification Name - Implant, Endosseous Dental, per 21 CFR § 872.3640 ## Devices for Which Substantial Equivalence is Claimed: - . Dentatus, Monorail Transitional Implant (MTI) #### Device Description: The Temporary Tooth Replacement is comprised of dental implant screws and prosthetic components. The system is designed to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. The system will consist of a screw and a molded pontic tooth that would be secured to the head of the screw using adhesive. The implant screw is removed once the patient reaches maturity and a permanent implant can be placed. #### Intended Use of the Device: The Temporary Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. ### Substantial Equivalence: The Temporary Tooth Replacement is substantially equivalent to other legally marketed devices in the United States. The Temporary Tooth Replacement functions in a manner similar to and is intended for the same use as the Monorail Transitional Implant (MTI) marketed by Dentatus. 7 1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design resembling an eagle or bird-like figure with three stylized wing or feather elements. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 2 4 2008 Ormco Corporation C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialist, Incorporated 1717 West Collins Avenue Orange, California 92867 Re: K081900 Trade/Device Name: Transitional tooth Replacement (TTR) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 20, 2008 Received: October 23, 2008 Dear Ms. Garman: 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}------------------------------------------------ Page 2 - Ms. Garman 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 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html. Sincerely yours, Khmuele Kind, mD for i Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K081900 ## Indications for Use 510(k) Number: K081900 Device Name: Transitional Tooth Replacement (TTR) Indications For Use: The Transitional Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors. 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 on (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices > > 510(k) Number: