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510(k) Data Aggregation

    K Number
    K061122
    Device Name
    NIGHT GUARD
    Manufacturer
    ALPINE ORAL CARE, LLC
    Date Cleared
    2007-03-12

    (322 days)

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

    ALPINE ORAL CARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding.
    Device Description
    NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
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