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510(k) Data Aggregation

    K Number
    K211158
    Device Name
    NTI ClenchGuard
    Manufacturer
    Boyd Research, Inc.
    Date Cleared
    2021-09-17

    (151 days)

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

    NTI ClenchGuard

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

    1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing;

    2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text only contains an FDA 510(k) clearance letter for the NTI ClenchGuard device. It does not include information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications.

    The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed how the NTI ClenchGuard compares to existing devices for the same intended use. The letter does not detail any novel studies conducted to prove the device meets specific acceptance criteria in the way you've described for an AI/algorithm-based device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information provided.

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