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510(k) Data Aggregation

    K Number
    K182661
    Device Name
    Kava and Kava with Herbst
    Date Cleared
    2019-02-13

    (141 days)

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

    Sketchpad Innovations LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Kava and Kava with Herbst are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The Kava and Kava with Herbst are intra-oral devices used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint. The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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