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510(k) Data Aggregation

    K Number
    K080308
    Device Name
    BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
    Manufacturer
    BIOSCAFFOLD INTERNATIONAL PTE LTD
    Date Cleared
    2008-04-14

    (69 days)

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

    BIOSCAFFOLD INTERNATIONAL PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bio-Scaffold Bioscaff Alvelac Scaffold is a bioabsorbable implantable matrix intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and conservation of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
    Device Description
    The Bioscaff™ Alvelac™ is a synthetic polymer scaffold synthesized from Poly (lactic-coglycolic) acid (PLGA) and poly vinyl acetate (PVA). The scaffold is designed with macro channels and micropores for cell adhesion, as well as to provide the necessary space for bone and tissues to grow.
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