Fill and Sign the Iso Insurance Forms PDF

33/-015 FEB 12 MPl 510(k) Summary of Safety and Effectiveness Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417 Contact Person: Peggy Hansen, RAC Sr. Director, Clinical, Regulatory, and QA Tel: (201) 405-1477 Fax: (201) 405-1355 Date of Summary: December 12, 2008 Device Common Name: Bone Grafting Material Device Trade Name: Synthetic Mineral - Collagen Bone Graft Matrix Device Classification Name: Bone Grafting Material, Synthetic 872.3930 LYC Class II Predicate Device(s): SynOss T M Synthetic Bone Graft Material K072397 OsteoGuideTM Anorganic Bone Mineral Products K043034 FOUNDATION TM Bone Filling Augmentation Material K040783 Description of the Device Synthetic Mineral - Collagen Bone Graft Matrix is a composite of synthetic calcium phosphate based granules and type I collagen. The calcium phosphate mineral has an apatite structure similar to that of natural bone. The type I collagen is derived from bovine Achilles tendon. The composite material is a resorbable, porous, osteoconductive bone graft matrix. The product is supplied in granular or block/plug form, and it is sterile, non-pyrogenic, and for single use only. Intended Use Synthetic Mineral - Collagen Bone Graft Matrix is intended for use in dental surgery. The products may be used in surgical procedures such as: * * · · * Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicocectomy, and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness Synthetic Mineral - Collagen Bone Graft Matrix * * Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration Summary/Comparison of Technical Characteristics Synthetic Mineral - Collagen Bone Graft Matrix and its predicates have the same technological characteristics. In particular, the Synthetic Mineral - Collagen Bone Graft Matrix and its predicates are the same with respect to intended use, material characterization, and product forms. Safety Synthetic Mineral - Collagen Bone Graft Matrix has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. Effectiveness The characteristics of the Synthetic Mineral - Collagen Bone Graft Matrix meet the design requirements for an effective bone grafting material in dental surgery. Conclusion The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the Synthetic Mineral - Collagen Bone Graft Matrix is safe and substantially equivalent to OsteoGuide Anorganic Bone Mineral with Collagen. DEPARTMENT OF HEALTH & HUMAN SERVICES FEB 12 2009 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Peggy Hansen President, Clinical, Regulatory, QA, and Marketing Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417 Re: K083742 Trade/Device Name: Synthetic Mineral - Collagen Bone Graft Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NPM Dated: December 12, 2008 Received: December 16, 2008 Dear Ms. Hansen: 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 the Act Include .rovisicn.of Th~:. pnera'controls controls provisions of :,S : requirements for annual registration, listing of devices, goodina~ufcturing 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. Page 2 - Ms. Hansen Please be advised that FDA's issuance of a substantialequivalence 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification, The FDA finding of substantia! equivalenceof 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industr,/support/index.html. ''.Sinae.ly yours, Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use 510(k) Number (if known): Device Name: __ __ _ __ __ _ __ ']k ' __ ' _ Synthetic Mineral - Collagen Bone Graft Matrix Indications for Use: Synthetic Mineral - Collagen Bone Graft Matrix is.intended .for.ube. in:'dental:surgery... The products may be used in surgical procedures such as: * · · · * · · Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicocectomy, and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration Prescription Use X (Part 21 CFR 801 Subpart D) . AND/OR Over-The-Counter Use (21 CFR 807 Subpart C), (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE-ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Off'i __----- ice Evaluation (ODE) (Division Sign.-0) -Division-of-Anesthesiology-Ge-fiera Hspital Infection Control, D Devices ental Page 1 of 1