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

    Glidewell Appliance Resin, Hard/Soft

    K Number: K214102 · Decision Feb 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    67
    Applicant Total
    27
    Review Days
    56

    Basic Information

    Device Name
    Glidewell Appliance Resin, Hard/Soft
    K Number
    K214102
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prismatik Dentalcraft, Inc.
    Date Received
    December 29, 2021
    Decision Date
    February 23, 2022
    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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