BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S006 · Decision Mar 28, 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
    S006
    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
    March 28, 2003
    Date Received
    June 17, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENSION OF THE EXPIRATION DATE ON EMDOGAIN GEL FROM 18 MONTHS TO 24 MONTHS.

    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