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510(k) Data Aggregation

    K Number
    K193357
    Device Name
    V-Mix
    Manufacturer
    Inter-Med/ Vista Dental Products
    Date Cleared
    2020-10-23

    (324 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K082470,K053167,K193409
    Why did this record match?
    Device Name :

    V-Mix

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

    V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

    Device Description

    V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.

    AI/ML Overview

    The provided document is a 510(k) K193357 Premarket Notification for the V-Mix device. It includes a general statement that "Clinical performance is not deemed necessary" and states that non-clinical tests were conducted to evaluate functionality, performance, safety, and substantial equivalence.

    Therefore, the document does not report on acceptance criteria or a study proving the device meets acceptance criteria in a clinical setting.

    It lists several non-clinical tests that were performed, but no details of these tests (such as specific methods, results, or acceptance criteria) are provided.

    Hence, I cannot extract the requested information as it is not present in the provided text.

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