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510(k) Data Aggregation

    K Number
    K050486
    Device Name
    PROTECT TOOTH DESENSITIZER
    Manufacturer
    SUNSTAR BUTLER
    Date Cleared
    2005-06-07

    (102 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K030922,K041680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNSTAR BUTLER

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

    Protect™ Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities.

    Device Description

    Protect™ Tooth Desensitizer is a film-like varnish.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are related to an FDA 510(k) submission for a tooth desensitizer, but they don't include details about a performance study, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. They primarily focus on regulatory aspects like classification, predicate devices, and intended use.

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