BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P170029 · Decision Mar 7, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Trade Name
    CALCIVIS Imaging System
    PMA Number
    P170029
    Product Code
    QJX
    Generic Name
    Caries detection product with drug or biologic
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 7, 2023
    Date Received
    September 26, 2017
    Expedited Review
    N
    Docket Number
    23M-0863

    Advisory Committee Statement

    Approval for The CALCIVIS Imaging System. The device 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 and treatment planning of demineralization associated with caries lesions.