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510(k) Data Aggregation

    K Number
    K180691
    Device Name
    TrueDorsal Devices
    Manufacturer
    True Function Laboratory, Inc.
    Date Cleared
    2019-02-11

    (332 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TrueDorsal Devices

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The use of TrueDorsal® Devices are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

    TrueDorsal® Device is a prescription only device that is customized by True Function Laboratory to dentist specific instructions. It is inserted and removed by the patient and adjusted by the prescribing dentist.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the TrueDorsal® Devices. It states that the device is substantially equivalent to legally marketed predicate devices for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed study specifics requested in the prompt. The letter is a regulatory clearance document, not a detailed study report.

    Therefore, I cannot fulfill the request using only the provided text. The information required (acceptance criteria, study details, etc.) is simply not present in this regulatory clearance letter.

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