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510(k) Data Aggregation

    K Number
    K190687
    Device Name
    Twilite Appliance
    Manufacturer
    Stephen J Harkins, DDS, PC
    Date Cleared
    2019-07-02

    (106 days)

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

    Stephen J Harkins, DDS, PC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.
    Device Description
    The Twilite Appliance ® is a customized oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The Twilite Appliance ® is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep.
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