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510(k) Data Aggregation

    K Number
    K240810
    Device Name
    Anti Grinding Guard
    Manufacturer
    Xiamen Yizhou Imp. & Exp. Co., Ltd.
    Date Cleared
    2024-05-24

    (60 days)

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

    **Xiamen Yizhou Imp. **& Exp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.
    Device Description
    The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.
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