DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

{0}------------------------------------------------ K0 72150 ## 510(k) SUMMARY SEP 1 3 2007 Confi-Dental Products Co. 416 So. Taylor Ave. Louisville, CO 80027 Date prepared: July 2007 Contact: Steve Rudolph Name: Dimer Acid Derived Nanohybrid Composite Classification name: Tooth shade resin material, 872.3690 Predicate devices: Crystalline L3 Multiuse hybrid K946307 3M Brand restorative K920425 Grandio K051867 #### Device description: Dimer acid derived nanohybrid composite is for use in all dental cavity classes. The composite is a single light cured paste with a different monomer system chemistry than other filling composites that are currently available. The new resin system produces exceptionally high conversion values with a very low shrinkage. #### Intended use: Dimer acid derived nanohybrid composite is indicated for class I, II, III, IV and V cavity classes. ### Substantial equivalence: Dimer acid derived nanohybrid composite is substantially equivalent to other legally marketed devices in the United States. A comparison of the performance data and indications for use to predicate devices indicates that the dimer acid derived nanohybrid composite functions in a manner similar to the predicate devices. {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 a stylized caduceus, which is a traditional symbol associated with medicine and healthcare. Public Health Service SEP 1 3 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Novocol, Incorporated C/O Mr. Steven Rudolph Quality Assurance/ Regulatory Affairs Manager Confi-Dental Products Company 416 South Taylor Avenue Louisville, Colorado 80027 Re: K072150 Trade/Device Name: Dimer Acid Derived Nanohybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 2, 2007 Received: August 6, 2007 Dear Mr. Rudolph: 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- Mr. Rudolph 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 regencies. You must comply with all the Act's requirements, including, but not imited to registers. and listing (21 CFR Part 807); labeling (21 CFR Part 801); good monufacturing 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 Activ 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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Clive Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K072150 Device Name: Dimer Acid Derived Nanohybrid Composite Indications for Use: "Dimer Acid Derived Nanohybrid Composite" is a light cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides simple esthetics since it is formulated in shades matching the VITA Lumin Shade guide. This low shrinkage nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Suver Qurns ംസ Sign-Off) .eneral Hospital, ്ഥാ of Anesthesioloي ാന്‍ശന Control, Dental Devices Number: K072150 Page 1 of ____________________________________________________________________________________________________________________________________________________________________