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    K Number
    K172760
    Device Name
    REST EAZY Appliance
    Manufacturer
    Insert Molding Solutions, Inc.
    Date Cleared
    2018-03-26

    (194 days)

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

    Insert Molding Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The REST EAZY Appliance is intended for use in adult patients for the reduction of snoring and mild to moderate obstructive sleep apnea. The REST EAZY Appliance is worn while sleeping to support the lower jaw in a forward position as prescribed by the dentist. The appliance is removable by the patient.
    Device Description
    The proposed REST EAZY Appliance device consists of an upper and lower acrylic splint, custom fabricated to the patient's teeth. The splints are connected to each other via the REST EAZY adjustable Herbst style mechanism that orients the jaw in a predetermined relationship. These devices function as a mandibular repositioner, which increases the pharyngeal space. An enlarged pharyngeal space assists the patient with improved air exchange. The device is custom fit for each patient, as prescribed by the dentist.
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