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510(k) Data Aggregation

    K Number
    K060122
    Device Name
    SLEEP SPLINT
    Date Cleared
    2006-05-19

    (122 days)

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

    NAKAGAWA DENTAL CLINIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.
    Device Description
    The Sleep Splint is a prescription only, intraoral appliance that is fitted to the upper and lower teeth, and worn during sleep for the purpose of reducing the incidence of snoring and obstructive sleep apnea. The Sleep Splint is made of copolyester (acrylic resin for the previous version) and features an orthodontic resin bond which can be custom-fitted by a dentist. It comfortably holds the mandible 5 mm to 7 mm forward.
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