BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Solution, Removal, Carries

    PMA: P000005 · Supplement: S001 · Decision Feb 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Solution, Removal, Carries
    Trade Name
    CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
    PMA Number
    P000005
    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
    February 5, 2002
    Date Received
    October 10, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CARISOLV POWER DRIVE.

    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