FIXTEMP C&B

{0}------------------------------------------------ 5. 510(k) Summary (per 21 CFR 807.92) 102917 ### 1) Applicant Information 10 May 2011 Sponsor Mr. Chase Wade EXACTA Dental Direct, Inc. . 44780 Macomb Industrial Dr. Clinton Township MI 48036 800-474-7665 / f- 416 322 7735 chase@exactadental.com Establishment registration No. #### 2) General Device Information Proprietary Name: Trade Name: Common Name Device Classification Name Classification Number: Product Code Review Advisory Committee Classification Advisory Committee Device Classification #### Consultant Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com 1836392 FixTemp C&B 1m FixTemp C&B ™ FixTemp C&B ™ Crown and Bridge Temporary resin. 21 CFR 872.3770 EBG Dental Dental Class II (nonexempt) ### 3) Predicate Device FixTemp C&B "" is substantially equivalent to other legally marketed devices in the United States. FixTemp C&B "" functions in a manner similar to and is intended for the same use as the original Temphase "" formulation that was manufactured by Kerr Dental Materials Center. | Predicate Device | Temphase tm, Temporary Dental Restorative Material.<br>See K020092..<br>Kerr Dental Materials Center<br>1717 West Collins Avenue<br>Orange, California 92867<br>Colleen Boswell | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device for K020092 | Kerr Corporation, TempFil C&B | Trademark Notice: All Trademarks used other than those of EXACTA Dental Direct, Inc. are registered to their respective owners. #### 4) Device Description The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Comments of the controlled to the control of the consisted to the controllable of the comments of the comments of the comments of the comments of the comments of the comments | CHANAGE AND A CALL A CHANNEL CONTRACT COLLEGIAL CONTRACT COLLEGIAL CONTRACT COLLEGION | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | EXACTA Dental Direct, Inc.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Page . | FixTemp C&B um | {1}------------------------------------------------ # 5. 510(k) Summary ## (per 21 CFR 807.92) FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification. The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics. ### 5a) Intended Use The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics. # 5b) Comparison to Predicate EXACTA Dental Direct, Inc. has determined that the FixTemp C&B "" device is substantially equivalent to the performance of the predicate device. The differences between our device and the predicate is incidental and not significant. Both our device and the predicate have the same technological and chemical characteristics. The FixTemp C&B"" device has the same technological characteristics when compared to the predicate device: - . The Indications for Use for the FixTemp C&B *** device is identical to the Temphase 100, Temporary Dental Restorative Material. - The Operational principals are the same. ● - Manufacturing materials and processes are similar. . Any differences do not affect the safety and effectiveness of the device when used as labeled. ### 5c) Bench Tests The following bench tests were conducted. ### Cytotoxicity. Cytotoxicity test was performed as Agar Diffusion Test with cured material, according to Din E N ISO 10993-5 (DIN/EN 30993-5). The recommended cell strain L929 (mouse fibroblasts) was used. Fixtemp C&B met the criteria of the test and was found to be non-cylotoxic. # Sensitization. The potential for sensitization of Fixtemp C&B was tested with a modified Guinea Pig Maximization Test (GMPT) according to Magnusson and Kligman (ASTM standards, Standard Practice F720-81), Under the test conditions, Fixtemp C&B did not induce any sensitization, | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | EXACTA Dental Direct, Inc. | Page 2 | FixTemp C&B "m | {2}------------------------------------------------ # 5. 510(k) Summary (per 21 CFR 807.92) ## Genotoxicity (Arnes-Test) Fixtemp C&B was tested with an Ames test for its genotoxic potential. Fixtemp C&B (extract) was non mutagenic in the Ames test either with or without metabolic activation, ### Carcinogenicity. A test for carcinogenicity was not conducted, as this test is only sensible according to DIN EN ISO 10993, if there are hints for such a suspect. in view of the extraordinarily low exposition levels and the negative genotoxicity and cytoxicity tests a test for carcinogenicity was not thought to be necessary. This conforms with procedures, that are generally applied for the testing of plastics. #### Implantation. Implantation of materials into the muscular tissue of rabbits is done to assess negative reactions of tissue towards biomaterials. If Fixtemp C&B is used as prescribed, the material only comes into contact with oral hard tissues and the surface of oral soft tissues. Therefore no implantation test for Fixtemp C&B was conducted, #### Acute Systemic Toxicity. The acute systemic toxicity is not explicitly obligatory according to DIN EN ISO 10993 and therefore was not specifically evaluated. Assessment of components In Fixtemp C&B that amount to more than 3%, have all a very low acute oral toxicity. They are generally used in dental materials in similar or even higher closes, which have already been reviewed and approved by the FDA, ### Inhalation Toxicity. Fixtemp C&B contains practically no volatile compounds and is not used as an aerosol. Therefore a test for inhalation toxicity, as suggested by the FDA G95-1 memorandum, was not thought useful and therefore was not conducted #### Test Conclusion Different in vivo and in vitro tests of Fixtemp C&B according to DN EN ISO 10993 have proven Fixtemp C&B to be not cytotoxic, not genotoxic and not sensitizing. ### Summary Based on the information, FixTemp C&B "" is substantially equivalent to Temphase "". {3}------------------------------------------------ # 102917 4. Indications for Use Statement 510(K) Number (If known): no 510(K) number assigned Device Name: FixTemp C&B 'm # Indications for Use FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges. U S.A. Federal Law restricts the dispensing of device except on the order of a licensed practitioner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | XXX | |------------------|--------------------------| | | or | | | Over - The - Counter Use | | | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EXACTA Dental Direct, Inc. | Page 7 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | FixTemp C&B 'm | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | And Charles of Children Comments of Children Comments of Children Comments of Children Comments of | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure. The logo is black and white. Food.and Drug_Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN 1 7 2011 Exacta Dental Direct, Incorporated C/O Mr. Richard Keen Vice President Operations Compliance Consultants 1151 Hope Street Stamford, Connecticut 06907-1659 Re: K102917 Trade/Device Name: Temphase™ Temporary Dental Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 23, 2011 Received: June 1, 2011 Dear Mr. Keen: 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. {5}------------------------------------------------ Page 2- Mr. Keent 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony D. nater Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {6}------------------------------------------------ # 102415 4. Indications for Use Statement 510(K) Number (If known): ____________________________________________________________________________________________________________________________________________________ no 510(K) number assigned Device Name: FixTemp C&B "" # Indications for Use FixTemp C&B "" is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges. U S.A. Federal Law restricts the dispensing of device except on the order of a licensed practitioner. Susan Runnes (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K102 K102917 | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)<br>Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------| | Prescription Use<br>XXX | <b>Or</b> | Over - The - Counter Use<br>(Per 21 CFR 801.109) | | | | (Optional Format 1-2-96 | | EXACTA Dental Direct, Inc. | Page 7 | |----------------------------|----------------| | | FixTemp C&B "" |