BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Implant, Endosseous, Root-Form

    PMA: P800035 · Supplement: S008 · Decision Nov 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333

    Basic Information

    Device Name
    Implant, Endosseous, Root-Form
    Trade Name
    AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG
    PMA Number
    P800035
    Supplement Number
    S008
    Device Class
    FDA Class 2
    Product Code
    DZE
    Generic Name
    Implant, endosseous, root-form
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 10, 1983
    Date Received
    October 11, 1983
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form