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510(k) Data Aggregation

    K Number
    K191618
    Device Name
    SleepTight Mouthpiece STZ
    Date Cleared
    2019-12-11

    (176 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Michael D Williams DDS PA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.
    Device Description
    The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. The STZ advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The STZ attaches to both upper and lower teeth which maintains a properly opened airway. The STZ utilizes a biocompatible thermoplastic mouthpiece material to treat snoring. The raw material is ethylene-vinyl acetate (EVA). The STZ uses the common boil and bite technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring.
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