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510(k) Data Aggregation

    K Number
    K033201
    Device Name
    LA500 BLUE LIGHT
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2003-12-02

    (61 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K020091
    Why did this record match?
    Device Name :

    LA500 BLUE LIGHT

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

    LA500 Blue Light is a visible curing unit programmed for This polymerization of light cured materials by dental professionals..

    Device Description

    APOZA CURING LIGHT, Models: LA500 Blue Light. The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a dental curing light, primarily focusing on its equivalence to a predicate device and its intended use. There is no mention of specific performance metrics, test sets, ground truth establishment, or expert involvement in a study.

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