BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P040013 · Supplement: S013 · Decision Aug 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Bone Grafting Material, Dental, With Biologic Component
    Trade Name
    GEM21S GROWTH FACTOR ENHANCED
    PMA Number
    P040013
    Supplement Number
    S013
    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
    August 29, 2008
    Date Received
    March 26, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) ADDITION OF A CLAIM THAT PDGF STIMULATES ANGIOGENESIS; 2) ADDITION OF A COMPARISON OF PIVOTAL CLINICAL TRIAL RESULTS OBTAINED WITH GEM 21S AND THE RESULTS PUBLISHED ON EMDOGAIN; AND 3) ADDITION OF 36 MONTH LONG TERM EFFICACY DATA TO THE ORIGINAL 6 MONTH STUDY.

    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