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510(k) Data Aggregation

    K Number
    K062289
    Device Name
    BONART ART-L3 LED CURING LIGHT
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2007-01-03

    (149 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BONART ART-L3 LED CURING LIGHT

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

    Source of illumination for curing dental is restorative materials.

    Device Description

    BONART ART-L3 LED CURING LIGHT

    AI/ML Overview

    This letter is a 510(k) clearance for a dental curing light, a device whose performance is assessed through physical characteristics rather than diagnostic accuracy. Therefore, the questions related to AI/algorithm performance (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable in this context.

    Summary of the Device:

    • Trade/Device Name: BONART ART-L3 LED CURING LIGHT
    • Regulation Number: 872.6070
    • Regulation Name: Ultraviolet Activator for Polymerization
    • Regulatory Class: II
    • Product Code: EBZ
    • Indication for Use: Source of illumination for curing dental restorative materials.

    The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls provisions of the Act.

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