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510(k) Data Aggregation

    K Number
    K112250
    Device Name
    CHX=CHX PLUS
    Manufacturer
    INTER-MED, INC.
    Date Cleared
    2011-10-28

    (85 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K070401,K103244,K924982,K053167,K061689
    Predicate For
    K160577
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing

    Device Description

    CHX and CHX-PlusTM are 2% Chlorhexidine Gluconate Solutions in water. CHX – PlusTM also contains wetting agents to lower surface tension. CHX and CHX-PlusTM are root canal cleansers for use in endodontic procedures. After endodontic instrumentation, these products should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating needle

    AI/ML Overview

    The provided text is a 510(k) summary for a dental device (root canal cleanser) and does not contain information about the acceptance criteria or a study proving that an AI device meets such criteria. The document explicitly states "Non-clinical Performance" for CHX and CHX-Plus™, indicating evaluations were related to the physical properties, efficacy, and biocompatibility of the chemical solution, not an AI algorithm.

    Therefore, I cannot provide the requested information based on the given input regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device.

    The document pertains to a chemical product, not an AI-powered medical device.

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