BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S003 · Decision Aug 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    EMDOGAIN
    PMA Number
    P930021
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NQA
    Generic Name
    Biologic material, dental
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 24, 1999
    Date Received
    May 20, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for packaging changes for EMDOGAIN(R). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.

    Classifications

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

    Product Code Device Name
    NQA Biologic Material, Dental