BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P040013 · Supplement: S008 · Decision Nov 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Bone Grafting Material, Dental, With Biologic Component
    Trade Name
    GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT
    PMA Number
    P040013
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NPZ
    Generic Name
    Bone grafting material, dental, with biologic component
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 17, 2006
    Date Received
    October 20, 2006
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD AAI PHARMA-WILMINGTON FACILITY AS A QUALIFIED FACILITY TO CONDUCT A BIOASSAY ON THE DRUG COMPONENT OF THE DEVICE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPZ Bone Grafting Material, Dental, With Biologic Component