BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P170029 · Supplement: S002 · Decision Nov 17, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Trade Name
    CALCIVIS Imaging System
    PMA Number
    P170029
    Supplement Number
    S002
    Product Code
    QJX
    Generic Name
    Caries detection product with drug or biologic
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 17, 2023
    Date Received
    May 25, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the premarket approval application (PMA) 180-day supplement, which requested approval for modifications to the device components to include the lens design, fluid delivery mechanism, wireless communication, dock chiller chamber, and applicator redesign. The proposed modifications are to produce a smaller handheld imaging system with added wireless communication for the ease of use accessibility. The CDRH of the FDA has also completed its review of the PMA 180-day supplement for the site change of TT Electronics Dongguan, Dongguan City, China.