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510(k) Data Aggregation

    K Number
    K962383
    Device Name
    PULPDENT RESILUTE II
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    1996-09-03

    (75 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pulpdent ResiLute IITM is a radiopaque, resin cement for the permanent cementation of dental inlays, crowns, bridges, veneers, posts, periodontal splints and for bonded amalgam techniques.

    Device Description

    Pulpdent ResiLute IITM is a radiopaque, resin cement... It is supplied as a chemical-cure or dual-cure two-paste system (base and catalyst), with and without fluoride, that mixes easily, and as a single light-cured paste, also with and without fluoride. Pulpdent ResiLute II™ has a very low film thickness and bonds to enamel, dentin, metals and ceramic.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental resin cement, Pulpdent ResiLute II™. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

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

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