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510(k) Data Aggregation

    K Number
    K152159
    Device Name
    Oravan Herbst
    Manufacturer
    Date Cleared
    2015-10-29

    (87 days)

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

    OravanOSA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults.
    Device Description
    The Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. It is made of orthodontic acrylic trays and herbst assembly. It has two acrylic pieces - the upper acrylic tray that fits over the top posterior teeth and the lower acrylic tray that fits over the bottom posterior teeth. The herbst assembly provides a standard titration mechanism and enables mandibular advancement. With this design, the Oravan Herbst allows the physician to increase the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. Each Oravan Herbst device is patient-specific (customized for each patient).
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