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    K Number
    K170606
    Device Name
    Acrylic Herbst Appliance with Micro-Recorder
    Manufacturer
    Gergen's Orthodontic Lab
    Date Cleared
    2017-11-16

    (260 days)

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

    Gergen's Orthodontic Lab

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older. When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.
    Device Description
    The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The micro-recorder is embedded within the appliance. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible. The micro-recorder permits a patient's compliance to prescribed oral therapy to be monitored. The patient contacting portions of the appliance are comprised of medical grade polymethylmethacrylate (acrylic splints) and) which are connected bilaterally via a stainless steel (Herbst) mechanism.
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