BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P170029 · Supplement: S004 · Decision Mar 3, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Trade Name
    CALCIVIS Imaging System
    PMA Number
    P170029
    Supplement Number
    S004
    Product Code
    QJX
    Generic Name
    Caries detection product with drug or biologic
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 3, 2025
    Date Received
    December 3, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the manufacturing scale up of the drug product (photoprotein) for use in the CALCIVIS Imaging System