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    K Number
    K113246
    Device Name
    OCS-B
    Manufacturer
    NIBEC COMPANY, LIMITED
    Date Cleared
    2013-01-16

    (441 days)

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

    NIBEC COMPANY, LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OCS-BTM cancellous and cortical granules are recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection; apicoectorny, and cystectorny - 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 (GBR)
    Device Description
    OCS-B™ is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
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