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510(k) Data Aggregation

    K Number
    K073685
    Device Name
    OTA COLLAGEN BIOMATERIAL
    Manufacturer
    OSSEOUS TECHNOLOGIES OF AMERICA
    Date Cleared
    2008-08-29

    (245 days)

    Product Code
    NPL, CLA, NPM
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSEOUS TECHNOLOGIES OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.
    Device Description
    OTA Collagen Biomaterial is an off-white, biocompatible, non-friable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. When moistened with water, saline, serum or blood, the porous material is flexible and conforms to the contours of the defect site. The material is easily cut with scissors or scalpel to meet the needs of the surgeon. OTA Collagen Biomaterial is non-pyrogenic and is provided sterile for single use only. OTA Collagen Biomaterial is available in four shapes and a number of sizes. It can be applied as an onlay to cover simple defects or can be used for bone graft containment.
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