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510(k) Data Aggregation

    K Number
    K170985
    Device Name
    Urbanek Device
    Manufacturer
    TMJ Services, LLC
    Date Cleared
    2017-09-25

    (175 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TMJ Services, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to aid in the relief of symptoms of TMD/TMJ.
    Device Description
    The Urbanek Device is an intraoral, maxillary posterior dis-occluding device designed to aid in the treatment of clenching and bruxing associated with TMD/TMJ. The purpose of the device is to keep posterior maxillary and mandibular teeth (molars and premolars) from occluding in the centric or eccentric positions. Constructed of heat cured dental resin and two metal ball clasps for retention, the device is customized for each patient (per prescription by a dentist). The device is designed to be worn for 24 hours per day (except at meals), 7 days per week for a set interval of time (e.g., 9 weeks). At scheduled follow-up visits, patients are assessed for symptom relief and the device inspected for comfort, proper design, excessive wear and vertical dimension for the inter-incisal distance with the device in place. The device may be adjusted for comfort and inter-incisal distance to ensure no posterior tooth or portion of a tooth occludes with the opposing tooth.
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