TRIONOMER

{0}------------------------------------------------ K022)50 Trionomer is a resin reinforced glass ionomer cementation system used for the following: - Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings; - . Luting metal inlays, onlays or crowns; - . Luting pre-fabricated and cast posts; - . Luting orthodontic appliances; - Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations ● recommending using conventional cements; - . Cavity liners; - Primary teeth cavity fillings; ● Non-stress bearing restorations such as class V fillings. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 1 2002 Pentron Clinical Technologies, LLC C/O Ms. Annmarie Tenero Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724 Re: K022150 Trade/Device Name: Trionomer Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 01, 2002 Received: July 02, 2002 Dear Ms. Tenero: 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. {2}------------------------------------------------ Page 2 - Ms. Tenero 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 vours. Patrizia Cucurachi/for Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # 5.0 INDICATION FOR USE STATEMENT ## 510(k) NUMBER (IF KNOWN): #### DEVICE NAME: Trionomer # INDICATION FOR USE: Trionomer is a resin reinforced glass ionomer cementation system used for the following: - Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings; - Luting metal inlays, onlays or crowns; . - Luting pre-fabricated and cast posts; ● - Luting orthodontic appliances; . - Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations . recommending using conventional cements; - . Cavity liners; - Primary teeth cavity fillings; . - Non-stress bearing restorations such as class V fillings. ● ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use / OR Over -The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Supan Grin 5.0 (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number: K022150 Pentron Clinical Technologies, LLC. 510K Submission - Trionomer