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510(k) Data Aggregation

    K Number
    K974649
    Device Name
    BIO-POST DENTAL POST SYSTEM
    Manufacturer
    ADVANCED AEROMEDICAL, INC.
    Date Cleared
    1998-05-01

    (140 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED AEROMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.
    Device Description
    The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.
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