BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    UnicLine Mobile

    K Number: K150490 · Decision Apr 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    1
    Review Days
    51

    Basic Information

    Device Name
    UnicLine Mobile
    K Number
    K150490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heka Dental A/S
    Date Received
    February 25, 2015
    Decision Date
    April 17, 2015
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EIA Unit, Operative Dental

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