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510(k) Data Aggregation

    K Number
    K231138
    Device Name
    Aniti-Snore Mouthguard+
    Manufacturer
    Oscimed SA
    Date Cleared
    2024-01-16

    (270 days)

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

    Oscimed SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to aid in the reduction of snoring for adults at least 18 years old.
    Device Description
    The Anti-Snore Mouthguard+ is a thermoforming mandibular advancement device to reduce snoring. The device works by pulling the lower jaw forward. As such, the entirety of the device is tissue-contacting. The device combines an upper and lower molding with thermal impression material to conform to user's teeth morphology with an adjustable mechanism to position the user's lower jaw according to the user's need. The Anti-Snore Mouthguard+ is a "Boil and Bite" device where both the upper and lower moldings are constructed out of moldable material when heated in a water bath with rigid frames that allow for the straps to be attached to adjust the fitting. The device additionally comes with a ventilated storage box and Instructions for Use. This ventilated storage box is only provided for storage when the device is not in use and does not impact intended use of the device.
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