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510(k) Data Aggregation

    K Number
    K040956
    Device Name
    HILUX LEDMAX 3
    Manufacturer
    FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC.
    Date Cleared
    2004-06-14

    (62 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This curing light is used to cure or set camphorquinone initiated materials used in the dental industry including composites, sealants and cements.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental curing light, the Hilux LEDMAX-3. It does not contain a study or detailed acceptance criteria for the device's performance. Instead, it states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information, as it is not present in the provided text. The document is an administrative clearance, not a technical performance report or study.

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