BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S008 · Decision Dec 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    EMDOGAIN GEL
    PMA Number
    P930021
    Supplement Number
    S008
    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
    December 2, 2003
    Date Received
    September 13, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATION FOR USE: "ENDOGAIN GEL IS INDICATED FOR USE IN CORONALLY POSITIONED FLAP PROCEDURES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS". THE DEVICE, WITH THIS ADDITIONAL INDICATION FOR USE, WILL BE MARKETED UNDER THE TRADE NAME ENDOGAIN GEL.

    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