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510(k) Data Aggregation

    K Number
    K991138
    Device Name
    LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
    Manufacturer
    LYSTA A/S
    Date Cleared
    1999-04-23

    (18 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K992236
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Polymerization of light-cured dental materials
    • Polymerization of restorative composite materials
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental curing light. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    Therefore, I cannot fulfill your request for that specific information based on the text provided.

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