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510(k) Data Aggregation

    K Number
    K093340
    Device Name
    PASR/QUIETNITE
    Date Cleared
    2010-06-11

    (228 days)

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

    EXACT SUPPLIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PAsr/QuietNite, a dentist prescribed mandibular repositioning/advancement device is intended for the treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea in persons 18 years of age or older. These devices are not indicated for the treatment of central apnea or severe obstructive sleep apnea and should only be prescribed by a Dentist after the undertaking of a sleep study.
    Device Description
    The PAsr QuietNite, a dentist prescribed mandibular repositioning device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes a PAsr QuietNite appliance for treatment, it is recommended that the patient receive a sleep study diagnosis.
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