BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CARIESCAN PRO

    K Number: K090598 · Decision Dec 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    285

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    Basic Information

    Device Name
    CARIESCAN PRO
    K Number
    K090598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cariescan , Ltd.
    Date Received
    March 5, 2009
    Decision Date
    December 15, 2009
    Product Code
    NBL
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBL Laser, Fluorescence Caries Detection

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