BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    I View and Imagen Sensor

    K Number: K162619 · Decision Nov 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    I View and Imagen Sensor
    K Number
    K162619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trident S.R.L
    Date Received
    September 20, 2016
    Decision Date
    November 4, 2016
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

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    Other Clearances by Trident S.R.L

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