BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P040013 · Supplement: S019 · Decision Oct 21, 2014
    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 ENHANCE MATRIX
    PMA Number
    P040013
    Supplement Number
    S019
    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
    Approved
    Decision Code
    APPR
    Decision Date
    October 21, 2014
    Date Received
    May 5, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW FILTRATION STEP AND RENOVATIONS AT THE SHIRLEY, NEW YORK MANUFACTURING FACILITY.

    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