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510(k) Data Aggregation

    K Number
    K101155
    Device Name
    AURADORM (NEUROMUSCULAR SLEEP)
    Manufacturer
    Date Cleared
    2011-05-12

    (381 days)

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

    SLEEPWRIGHT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.
    Device Description
    The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and the effects of mild to moderate obstructive sleep apnea. The one piece upper and lower tooth engaging appliance covers the occlusal and buccal aspects of the entire lower arch teeth and the occlusal and buccal aspects of the posterior maxillary teeth to include the maxillary canines. The maxillary central and lateral incisors do not touch the appliance. The device does not rest or impinge on soft tissue. The oral appliance is prescribed by a dentist and custom fit to the patient's mouth in the dental clinic. The oral appliance is made of FDA approved dental acrylic or resin, stainless steel ball clasps and orthodontic stainless steel braid embedded in the acrylic for strengthening purposes. The appliance is designed to limit the amount of material on the lingual aspect of the teeth and still maintain the anti-snoring functionality based on the predicate devices. The appliance has an anterior opening to prevent restriction of mouth breathing and is reinforced with orthodontic stainless steel metal braid embedded in the acrylic. Ball clasps are situated in the appliance to provide upper and lower tooth retention and adjustability for patient comfort.
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