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510(k) Data Aggregation

    K Number
    K060122
    Device Name
    SLEEP SPLINT
    Manufacturer
    NAKAGAWA DENTAL CLINIC
    Date Cleared
    2006-05-19

    (122 days)

    Product Code
    LRK,COM
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K882303,K954530
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The providing text does not include information about acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification for the Sleep Splint device, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and intended use. It does not contain clinical study data, performance metrics, or details about how acceptance criteria were established or met through testing.

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