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

    Glidewell TuffSplint™ Appliance Resin

    K Number: K223798 · Decision Feb 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    57
    Review Days
    60

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    Basic Information

    Device Name
    Glidewell TuffSplint™ Appliance Resin
    K Number
    K223798
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prismatik Dentalcraft, Inc.
    Date Received
    December 19, 2022
    Decision Date
    February 17, 2023
    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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