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510(k) Data Aggregation

    K Number
    K101827
    Device Name
    OSTEOSCAF
    Manufacturer
    TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL
    Date Cleared
    2011-04-20

    (293 days)

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

    TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
    Device Description
    OsteoScaf™ is a synthetic osteoconductive and bioresorbable bone grafting material composed of 3-phase biodegradable polymer and calcium phosphate composite, intended to fill and/or augment intraoral/maxillofacial osseous defects. It functions in the same manner as the predicate devices. The product is available as a particulate, cylinder, or block and is provided in sterile packaging in various dosage volumes.
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