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510(k) Data Aggregation

    K Number
    K210910
    Device Name
    Snore Bandit
    Manufacturer
    Date Cleared
    2021-07-01

    (94 days)

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

    SnoreBandit LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
    Device Description
    The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit 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. The product is non-sterile and provided in a sealed box with instructions.
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