Fill and Sign the Personal Care Aide Curriculum Answers Form

Re: K103087 Trade/Device Name: CovaTmMAX Resorbable Membrane for Guided Tissue and Bone Regeneration Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: August 23, 2011 Received: August 24, 2011 Dear Ms. Centis: We have reviewed your Section 5 10(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 td 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: CDR- 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. Page 2 - Ms. Centis 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 /ucmlI 15809.htm for the Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.g~ov/MedicalDevices/Safety/ReportaProblemldefault.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 httip://www.fda.g~ov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Athony D.Wtsn . 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 /cU308 7 Indications for Use 510(k) Number (if known): CovaTM MAX Resorbable Membrane for Guided Tissue and Bone Regeneration Device Name: Indications for Use: Cova' hMAX is intended for use in oral surgicM procedures as a resorbable membrane material for use in: -Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Filling of bone defects after root resection, cystectomy and removal of retained teeth; -Guided bone regeneration in dlehiscence defects; -Guided tissue regeneration procedures in periodontal and recession defects. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: ___________Page 1lof 1