BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S010 · Decision Nov 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    EMODOGAIN
    PMA Number
    P930021
    Supplement Number
    S010
    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
    November 28, 2007
    Date Received
    October 9, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE: 1) A MODIFICATION OF THE DESCRIPTION OF EMODOGAIN, AND 2) A RESTRICTION OF THE RECOMMENDATION TO THE USE OF PREFGEL TOOTH CONDITIONER.

    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