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510(k) Data Aggregation

    K Number
    K181123
    Device Name
    ApnoDent Appliance
    Manufacturer
    Date Cleared
    2018-11-21

    (205 days)

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

    ApnoMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
    Device Description
    The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward. The ApnoDent® design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort. The ApnoDent® appliance consists of upper and lower interlocking, customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user.
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