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510(k) Data Aggregation

    K Number
    K110178
    Device Name
    ESTELITE COLOR
    Manufacturer
    TOKUYAMA DENTAL CORPORATION
    Date Cleared
    2011-04-05

    (74 days)

    Product Code
    EBF,EST
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ESTELITE COLOR tooth shade resin material is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.

    Device Description

    ESTELITE COLOR is a low viscosity light-cured tint for individualized shade characterizations. The device comes in a paste, packaged in a syringe. The device contains silica zirconia and silica-titania filler. All ingredients have been cleared for use by the FDA in similar devices.

    AI/ML Overview

    The provided text describes the 510(k) summary for the ESTELITE COLOR device, a tooth shade resin material. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details for an AI/ML device.

    This document is for a traditional medical device (tooth shade resin material) and outlines its substantial equivalence to predicate devices based on design, material, chemical composition, and physical properties testing, rather than AI/ML performance metrics.

    Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details based on this input.

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