BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Solution, Removal, Carries

    PMA: P830035 · Supplement: S001 · Decision Apr 18, 1985
    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
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LMW
    Generic Name
    SOLUTION, REMOVAL, CARRIES
    Medical Specialty
    Unknown
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 1985
    Date Received
    October 1, 1984
    Expedited Review
    N

    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