BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Acrylic Herbst Appliance with Micro-Recorder

    K Number: K170606 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    260

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    Basic Information

    Device Name
    Acrylic Herbst Appliance with Micro-Recorder
    K Number
    K170606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gergen'S Orthodontic Lab
    Date Received
    March 1, 2017
    Decision Date
    November 16, 2017
    Product Code
    PLC
    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
    PLC Sleep Appliances With Patient Monitoring

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