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510(k) Data Aggregation

    K Number
    K183315
    Device Name
    CustMBite Dental Guard
    Manufacturer
    Dental Choice Holdings, LLC
    Date Cleared
    2019-08-23

    (266 days)

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

    Dental Choice Holdings, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism – the nighttime clenching and grinding of the teeth. It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding. The CustMBite Dental Guard is intended for individuals age 18 and older.
    Device Description
    CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.
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