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510(k) Data Aggregation

    K Number
    K190058
    Device Name
    PureSleep (OTC use)
    Manufacturer
    Sleep Science Partners, Inc.
    Date Cleared
    2019-04-11

    (90 days)

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

    Sleep Science Partners, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep
    Device Description
    The PureSleep® device for Over-the-Counter (OTC) use is an intraoral mandibular repositioning device that increases the pharyngeal space to improve the user's ability to exchange air and to decrease air turbulence, a causative factor in snoring. The device consists of two dental trays designed to conform to the shape of the upper and lower jaws.
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    K Number
    K113022
    Device Name
    PURESLEEP
    Manufacturer
    SLEEP SCIENCE PARTNERS, INC.
    Date Cleared
    2012-06-11

    (244 days)

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

    SLEEP SCIENCE PARTNERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.
    Device Description
    PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The PureSleep device has three adjustments for forward mandibular advancement, 4mm apart anteriorly, while maintaining a 9mm inferior placement for patient comfort. The PureSleep device is formed to the upper and lower teeth similar to an athletic mouth guard. When boiled, the outer resin holds its shape, while the inner resin softens, which adapts to the teeth when bitten. To prepare for the fitting, the upper and lower components are attached at the proper setting depending on the patient's bite, using either the two holes closest to the front of the device, the center holes, or the two holes closest to the back of the device. The device is boiled in water for one minute, allowed to cool for 14 to 18 seconds. Holding the mouth open and lower jaw forward, the patient places the PureSleep device in the mouth and bites down firmly for 45 seconds. Upon removal of the device, excess material can be trimmed for greater comfort. The device can be re-boiled up to three times to achieve the best impression. PureSleep is simple to fit and does not require impressions or lab-fabrication.
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