BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Xcam

    K Number: K192700 · Decision Dec 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    183
    Applicant Total
    3
    Review Days
    92

    Basic Information

    Device Name
    Xcam
    K Number
    K192700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HDX WILL Corp.
    Date Received
    September 26, 2019
    Decision Date
    December 27, 2019
    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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    Other Clearances by HDX WILL Corp.

    K Number Device Name
    K211159 eco-x Series (eco-x, eco-x-s)
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