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510(k) Data Aggregation

    K Number
    K232238
    Device Name
    Goyo Mouthpiece S
    Manufacturer
    Dimedikorea
    Date Cleared
    2024-04-17

    (264 days)

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

    Dimedikorea

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
    Device Description
    The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.
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