CERCOM II CEMENT

{0}------------------------------------------------ K13 2393 Image /page/0/Picture/1 description: The image shows a date written in bold black font. The date reads "MAR 1 4 2014". The month is abbreviated, followed by the day and year. ### ali corporation 131100d Washington Studi 11.100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 1 70, 826, 910, 9 : "KI 12-11-14-11 13 வர் விச்சர்களையும் கா 510 (k) Summary November 25, 2013 ADDRESS DENALI CORPORATION 134 Old Washington Street Hanover, MA 02339-1629 OWNER/CONTACT PERSON Dr. Jan G. Stannard TEL: 781-826-9190 FAX: 781-826-4465 j.stannard@denalicorporation.com TRADE NAME CERCOM II COMMON NAME Resin Cement CLASSIFICATION NAME DENTAL CEMENT (21 CFR 872.3275, Product Code EMA) REGISTRATION 3006367836 PREDICATE DEVICES Cercom Cement/Denali Corporation - RelyX Cement/ESPE/3M Variolink Cement/Ivoclar - Calibra Cement/Dentsply - Nexus Cement/Kerr EQUIVALENCE The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EMA 872.3275, Dental Cement. DEVICE DESCRIPTION CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. INTENDED USE CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended TECHNOLOGICAL CHARACTERISTICS use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure. SUBSTANTIAL CERCOM II Cement is substantially equivalent in design. EQUIVALENCE composition, performance, intended use and effectiveness to the predicate cement products cited. This assessment is based upon a comparison of the physical characteristics, mechanisms of use description, intended use, composition, and mechanical properties of the cited predicate products. SUMMARY CONCLUSIONS CERCOM II Cement has been found to be substantially equivalent > in design, composition, performance, intended use and effectiveness to the predicate cement products cited. {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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 14, 2014 Denali Corporation Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629 Re: K132393 Trade/Device Name: CERCOM II Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Resin Cement Regulatory Class: II Product Code: EMA Dated: December 4, 2013 Received: December 6, 2013 Dear Dr. Stannard: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Erin I. Keith -S Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain peak to the left of the text "denali corporation". The text is in a bold, sans-serif font. #### INDICATIONS FOR USE STATEMENT 510 (k) Number 132393 (if known) Device Name ## CERCOM II Cement #### Indications for Use: CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. Please do not write below this line. Continue on another page if needed. Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S. Runner -S Susan Runner DDS, MD 2014.03.13 09:33:50 -04'00' 0 Image /page/3/Picture/11 description: The image shows a black square with a large "X" inside of it. The "X" is also black and fills most of the square. The lines of the "X" are thick and bold. The image is simple and lacks any background detail. Prescription Use (Per 21 CFR 801.109) or Over-The-Counter Use