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510(k) Data Aggregation

    K Number
    K090436
    Device Name
    AIRWAYEASE MAS
    Date Cleared
    2010-04-16

    (421 days)

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

    ORTHOPLANT DENTAL LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnoea. The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
    Device Description
    The Airwayease MAS is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnoea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of interchangeable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement as well as vertical change to be set by the dentist or physician at the time of fitting the device. The ranges of mandibular advancement are up to 7mm from the starting point of the construction bite supplied by the dentist, as well as 7mm of vertical opening from the starting point of the construction bite supplied by the dentist. Lateral movement of the jaw is limited by the device and as such this device is contra-indicated for those patients requiring the ability to move their lower jaw in a lateral direction whilst wearing the device. Vertical opening for the Airwayease MAS is unrestricted except by that of the patient's individual physiology.
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