TEMPFIL

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white. FEB 0 4 2002 ## Section III - 510(k) Summary of Safety and Effectiveness K013895- #### Submitter: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person November 2001 Date Summary Prepared: #### Device Name: - Trade Name TempFil . - Common Name Temporary Dental Restorative Material . - . Classification Name - Temporary Crown and Bridge Resin, per 21 CFR § 872.3770 #### Devices for Which Substantial Equivalence is Claimed: - Kerr Corporation, TempFil F 2 . #### Device Description: TempFil is a light cured single component temporary filling material designed for fabrication of provisional inlays and onlays. TempFil contains a resin base, which provides a sculptable viscosity with non-sticky placement. Available in syringe and unidose delivery systems; TempFil sets to a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts. #### Intended Use of the Device: The intended use of TempFil is for temporary filling of inlay and onlay preparations, implant screw and endodontic access openings, and for the emergency replacement of lost fillings. #### Substantial Equivalence: TempFil is substantially equivalent to other legally marketed devices in the United States. TempFil functions in a manner similar to and is intended for the same use as the original TempFil F - 2 formulation that was manufactured by Kerr Corporation. {1}------------------------------------------------ Image /page/1/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 an abstract symbol that resembles an eagle or bird in flight, with three stylized wave-like lines beneath it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 0 4 2002 Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867 Re: K013895 Trade/Device Name: TempFil Regulation Number: 872.3770 Regulation Name: Temporary Dental Restorative Material Regulatory Class: II Product Code: EBG Dated: November 20, 2001 Received: November 23, 2001 Dear Ms. Boswell: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales over 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 Nr.), It may of cashed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In Jour device FDA may publish further announcements concerning your device in the Federal Register. 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 mean that I any Federal statutes and regulations administered by other Federal agencies. {2}------------------------------------------------ #### Page 2 - Ms. Boswell 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 your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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, Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Section I # Indications for Use Statement Ver/3-4/24/96 Applicant: Kerr Dental Materials Center 510(k) Number (if known): K013895 Device Name: TempFil Indications For Use: *TempFil* is a light-cured, single component temporary filling material intended to be used for filling of inlay and onlay preparations, implant screw and endodontic access openings, and for the emergency replacement of lost fillings. (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) (Optional Format 1-2)Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number KG13895-