BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VistaCam iX Proof

    K Number: K150672 · Decision Jan 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    317

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    Basic Information

    Device Name
    VistaCam iX Proof
    K Number
    K150672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Durr Dental AG
    Date Received
    March 16, 2015
    Decision Date
    January 27, 2016
    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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