BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Grafting Material, Animal Source

    PMA: P860012 · Supplement: S001 · Decision Dec 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50

    Basic Information

    Device Name
    Bone Grafting Material, Animal Source
    Trade Name
    ALVEOFORM TM BIOGRAFT
    PMA Number
    P860012
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    NPM
    Generic Name
    BONE GRAFTING MATERIAL, ANIMAL SOURCE
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 13, 1988
    Date Received
    November 9, 1988
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    NPM Bone Grafting Material, Animal Source