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510(k) Data Aggregation

    K Number
    K250122
    Device Name
    SleepRight Snore Aid
    Manufacturer
    Splintek Inc.
    Date Cleared
    2025-05-19

    (122 days)

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

    Splintek Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring. The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.
    Device Description
    The SleepRight Snore Aid is a customizable adjustable, in 1mm increments up to 6mm total, intraoral mandibular advancement device (MAD). An adjustable stop moves the lower tray, which moves the mandible, to the desired user setting of a position that increases (opens) the pharyngeal space (airway), which aids in minimizing air obstruction and aids in the reduction of snoring during sleep. The SleepRight Snore Aid consists of two independent, customizable moldable, via hot (not boiling) water and bite method, removable, thermoplastic resin injection molded trays, fitted into the user's mouth, that fit separately over the upper (maxillary) and lower (mandibular) dental arches. The upper tray is provided with an adjustable advancement stop mechanism, one on each side of the rear of the upper tray, that provides the incremental 1mm up to 6mm total adjustment. The lower tray is provided with a fin, one on each side of the tray. As the adjustable advancement stop mechanism on each side of the upper tray is incrementally adjusted, the adjustable advancement stop mechanism on each side of the upper tray engages the fin, in a mating position on each side of the lower tray, stabilizing the mandible in a neutral posture or advances the mandible forward until the desired position that opens the airway and aids in a reduction of snoring during sleep is obtained by the user. Because the mandible is attached to the Oropharynx airway tissues (throat), and its posterior movement collapses the airway, stabilizing the mandible in a neutral or advanced forward position opens the airway for improved breathing. Having two independent dental arch trays allows for freedom of movement of the jaw musculature resulting in more user comfort, compliance and efficacy. Necessary Inspiratory and expiratory rapid expulsion of air is also improved.
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