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    K Number
    K111009
    Device Name
    ACRYLIC HERBST APPLIANCE
    Manufacturer
    EMBASSY DENTAL LABORATORY
    Date Cleared
    2011-07-22

    (102 days)

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

    EMBASSY DENTAL LABORATORY

    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 apnea (OSA) in adults 18 years of age or older.
    Device Description
    The Acrylic Herbst Appliance is comprised of custom-fabricated acrylic splints (methylmethacrylate) which are connected bilaterally via a telescoping Herbst mechanism (stainless steel).
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