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510(k) Data Aggregation

    K Number
    K123410
    Device Name
    HEALTHY SLEEP APPLIANCE
    Date Cleared
    2013-04-05

    (151 days)

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

    HEALTHY SLEEP DENTAL LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
    Device Description
    The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.
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