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510(k) Data Aggregation

    K Number
    K181361
    Device Name
    Brux Night Guard
    Manufacturer
    Brux Night Guard
    Date Cleared
    2019-04-11

    (323 days)

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

    Brux Night Guard

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

    The Brux Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted for the Brux Night Guard. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use, but no performance data or study details.

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

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