FLASH BITE

{0}------------------------------------------------ # MAR - 6 2014 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### Submitter | Company: | 3M Deutschland GmbH | |-----------------------------------|---------------------------------------------------------| | Street: | ESPE Platz | | ZIP-Code, City: | 82229 Seefeld | | Federal State: | Bavaria | | Country: | Germany | | Establishment Registration Number | 9611385 | | Official Correspondent: | Dr. Desi W. Soegiarto,<br>Regulatory Affairs Specialist | | Phone Official Correspondent: | +49-8152-700 1169 | | Fax Official Correspondent: | +49-8152-700 1869 | | E-mail Official Correspondent: | desi.soegiarto@mmm.com | | Contact Person | Ruediger Franke,<br>Regulatory Affairs Specialist | | Phone Contact Person: | +49-8152-700 1802 | | Fax Contact Person: | +49-8152-700 1869 | | E-mail Contact Person: | ruediger.franke@3M.com | | Date: | October 29, 2013 | #### Name of Devices | Proprietary Name: | Flash Bite | |----------------------|-----------------------------------------------| | Classification Name: | Impression material | | Common Name: | Vinyl polysiloxane bite registration material | {1}------------------------------------------------ #### Predicate Devices | Dimension Bite<br>by 3M Deutschland GmbH, Germany | K991008 | |---------------------------------------------------|---------| | Flash AR Penta<br>by 3M Deutschland GmbH, Germany | K131404 | #### Description for the Premarket Notification Flash Bite is classified as impression materials (21 C.F.R. § 872.3660) because it is a devices intended to reproduce the structure of a patient's teeth. Flash Bite has been developed based on Dimenson Bite of 3M Deutschland GmbH (K991008), a predicate device to which Flash Bite has been compared. Like Dimension Bite, Flash Bite is a two component (base paste/catalyst) vinyl polysiloxane bite registration material designed to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 1:1 (by volume). In this 510(k) premarket notification Flash Bite has been compared to the predicate devices Dimenson Bite of 3M Deutschland GmbH (K991008) and Flash AR Penta of 3M Deutschland GmbH (K131404) with regard to indications for use, physical and mechanical properties, and chemical composition. The comparison for indications for use, performance data, and chemistry shows that Flash Bite is substantially equivalent to the predicate devices. Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Bite in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash Bite material is biocompatible for its intended use. In summary, it can be concluded that Flash Bite is as substantially equivalent in safety and effectiveness as the predicate devices Dimension Bite and Flash AR Penta by 3M Deutschland GmbH. {2}------------------------------------------------ , : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . . Indications for Use: · Bite registration . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 6, 2014 3M Deutschland GmbH Dental Products Mr. Ruediger Franke Regulatory Affairs ESPE Platz D-82229 Seefeld GERMANY Re: K133400 Trade/Device Name: Flash Bite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 11, 2013 Received: December 13, 2013 Dear Mr. Ruediger: 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. {4}------------------------------------------------ Page 2 - Mr. Ruediger 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm. Sincerely vours. Image /page/4/Picture/7 description: The image shows the text "Erin Keith -S". The text is in a bold, sans-serif font. The words "Erin" and "-S" are in a simple, blocky font, while the word "Keith" is stylized with a more complex, geometric design. The overall impression is a combination of simplicity and complexity. Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ . .... ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ## Indications for Use 510(k) Number (if known): K133400 Device Name: Flash Bite Indications For Use: Bite registration. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mages Runner -5 Sean Runyon 2014.03.06 10:02:23 -05'00' Page 1 of _1 :