BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P170029 · Supplement: S003 · Decision Oct 13, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Trade Name
    CALCIVIS Imaging System
    PMA Number
    P170029
    Supplement Number
    S003
    Product Code
    QJX
    Generic Name
    Caries detection product with drug or biologic
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 13, 2023
    Date Received
    September 12, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    24M-4267

    Advisory Committee Statement

    Approval for the CALCIVIS Imaging System is intended to be used by dental healthcare professionals on patients (6 years and older) with, or at risk of developing, demineralization associated with caries lesions, on accessible coronal tooth surfaces. The CALCIVIS Imaging System is indicated for use to provide images of active demineralization on tooth surfaces, as an aid to the assessment, diagnosis, monitoring and treatment planning of demineralization associated with caries lesions.