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510(k) Data Aggregation

    K Number
    K173275
    Device Name
    OMNICHROMA
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2018-02-27

    (138 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K121583,K112501,K080940,K051808,K161353,K010267
    Why did this record match?
    Reference Devices :

    K121583, K112501, K080940, K051808, K161353

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

    For use as a tooth shade resin material in dental procedures, such as:

    • Direct anterior and posterior restorations
    • Direct bonded composite veneer
    • Diastema closure
    • Repair of porcelain/composite
    Device Description

    The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.

    The device does not come sterilized and is not intended to be sterilized prior to use.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the OMNICHROMA tooth shade resin material. It does not contain information about a comparative effectiveness study involving AI or human readers, nor does it detail acceptance criteria and performance data in the context of an AI device. The document is for a dental restorative material, not an AI-powered diagnostic or assistive device.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and reported device performance related to an AI device.
    • Sample sizes, data provenance, and expert details for a test set for an AI device.
    • Adjudication methods for an AI device's test set.
    • MRMC study details or effect sizes for human readers with/without AI assistance.
    • Standalone performance for an AI algorithm.
    • Ground truth types in the context of AI.
    • Training set sample size and ground truth establishment for an AI device.

    The provided document focuses on the physical and chemical properties of a dental resin and its substantial equivalence to a predicate device based on non-clinical testing according to ISO 4049. There is no mention of AI, diagnostic performance, or human reader studies.

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