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

    RiX70 DC

    K Number: K182206 · Decision Sep 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    RiX70 DC
    K Number
    K182206
    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
    August 15, 2018
    Decision Date
    September 13, 2018
    Product Code
    EHD
    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
    EHD Unit, X-Ray, Extraoral With Timer

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