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

    THERMOFORMED MOUTHGUARDS

    K Number: K121365 · Decision Nov 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    197

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    Basic Information

    Device Name
    THERMOFORMED MOUTHGUARDS
    K Number
    K121365
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glidewell Laboratories-Sleep Devices Group
    Date Received
    May 7, 2012
    Decision Date
    November 20, 2012
    Product Code
    MQC
    Advisory Committee
    Unknown
    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
    MQC Mouthguard, Prescription

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