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510(k) Data Aggregation

    K Number
    K082723
    Device Name
    GRINDGUARD
    Manufacturer
    GRIND GUARD TECHNOLOGIES, LLC
    Date Cleared
    2009-08-31

    (348 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K073220,K010876,K962516,K900389
    Predicate For
    K123161,K133037
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.

    Device Description

    The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower incisors and an internal layer, which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and the inner, moldable layer consists of polycaprolactone.

    AI/ML Overview

    The provided document is a 510(k) summary for the GrindGUARDN mouthguard, which is a traditional submission asserting substantial equivalence to predicate devices. It describes the device, its intended use, and lists predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory submission process and the determination of substantial equivalence, not on the results of performance studies against specific acceptance criteria.

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