BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Solution, Removal, Carries

    PMA: P830035 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Solution, Removal, Carries
    Trade Name
    GK-101E CARIES REMOVAL AGENT/SYSTEM
    PMA Number
    P830035
    Device Class
    FDA Class 3
    Product Code
    LMW
    Generic Name
    SOLUTION, REMOVAL, CARRIES
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 6, 1984
    Date Received
    July 1, 1983
    Expedited Review
    N
    Docket Number
    84M-0248

    Classifications

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

    Product Code Device Name
    LMW Solution, Removal, Carries