BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Solution, Removal, Carries

    PMA: P830035 · Supplement: S003 · Decision Nov 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Solution, Removal, Carries
    Trade Name
    CARIDEX(TM) REMOVAL SYSTEM
    PMA Number
    P830035
    Supplement Number
    S003
    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
    November 25, 1987
    Date Received
    June 6, 1986
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    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