LC TEMPORARY FILLING

{0}------------------------------------------------ ## SEP = 6 2001 . . . . K012360 # PG : ### 510(k) SUMMARY | Submitter: | Parkell, Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: 631-249-1134<br>FAX: 631-249-1242 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735 | | Submission Date: | 18 July 2001 | | Trade Name: | LC Temporary Material | | Common Name: | Light Cured Temporary Filling Material | | Classification Name: | Temporary Crown & Bridge Resin | | Equivalence: | Fermit N, Tempfil F, Tempfil C&B, Tempfil F-2, LC Provifill. | | Description/Intended Use: | A light-cured resin intended for use as a temporary<br>restorative material in a tooth prepared to receive an<br>inlay or onlay until such time as the laboratory fabricated<br>final restoration can be inserted into that tooth. | PARKELL INC. • 155 Schmitt Blvd., Farmingdale, NY 11735 USA • 631-249-1134 Toll-Frec 1-800-243-7446 • Fax: 631-249-1242 • E-Mail: info@parkell.com {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure in profile, with three horizontal lines above the head, representing growth and development. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure. #### Public Health Service SEP = 6 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735 Re: K012360 > Trade/Device Name: LC Temporary Filling Regulation Number: 21 CFR 872.3770 Regulation Name: Light-Cured Temporary Filling Materials Regulatory Class: Class II Product Code: EBG Dated: July 18, 2001 Received: July 25, 2001 Dear Dr. Gendusa: 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. 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. {2}------------------------------------------------ #### Page 2 -- Dr. Gendusa 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, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page ____ of _________________________________________________________________________________________________________________________________________________________________ Ko 2360 510(k Number (if known):_ Device Name: _LC Temporary Filling Indications for Use: or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth. ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K012360