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510(k) Data Aggregation

    K Number
    K223624
    Device Name
    Emerald Herbst
    Date Cleared
    2023-05-10

    (156 days)

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

    Island Dental Lab, Inc dba Emerald Dental

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
    Device Description
    The Emerald Herbst 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 and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device. The Emerald Herbst appliance is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. The Emerald Herbst is offered in two options: - Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if it becomes loose. - Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.
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