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510(k) Data Aggregation

    K Number
    K060946
    Device Name
    CZ-S2000
    Manufacturer
    PARKELL, INC.
    Date Cleared
    2006-06-15

    (70 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder and liquid) root canal sealer that is capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.

    Device Description

    A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder/liquid) root canal sealer capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.

    AI/ML Overview

    The provided text is a 510(k) summary for a root canal sealer, not a study evaluating acceptance criteria for a device's performance. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

    The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device's intended use and classification but offers no performance data or study results.

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