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510(k) Data Aggregation
K Number
K093340Device Name
PASR/QUIETNITE
Manufacturer
Date Cleared
2010-06-11
(228 days)
Regulation Number
872.5570Why 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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