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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Solution, Removal, Carries

    PMA: P000005 · Decision Jun 27, 2001
    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
    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    Approved (Withdrawn)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
    June 27, 2001
    Date Received
    January 10, 2000
    Expedited Review
    N
    Docket Number
    01M-0337

    Advisory Committee Statement

    APPROVAL FOR THE CARISOLV(TM) NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM. THE DEVICE IS INTENDED FOR THE CHEMO-MECHANICAL SOFTENING AND REMOVAL OF DENTIN CARIES WHEN USED IN CONJUNCTION WITH A DENTAL HANDPIECE.

    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