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510(k) Data Aggregation

    K Number
    K031212
    Device Name
    TEMPORARY RESIN CEMENT
    Manufacturer
    PARKELL, INC.
    Date Cleared
    2003-07-11

    (85 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K101044
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A radiopaque, self-cure, resin-based temporary cement that is used to lute provisional restorations such as crowns, inlays, onlays, fixed bridges, laminate veneers, etc. or to temporarily cement permanent dental restorations.
    A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.

    Device Description

    A radiopaque, self-cure, resin-based temporary cement

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.

    The document is a 510(k) summary for a dental temporary cement, outlining its intended use, classification, and substantial equivalence to predicate devices. It does not contain details about specific performance metrics or clinical study results.

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