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510(k) Data Aggregation

    K Number
    K163605
    Device Name
    LEDEX WL070+
    Manufacturer
    DENTMATE TECHNOLOGY CO., LTD.
    Date Cleared
    2017-01-19

    (29 days)

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

    LEDEX WL070+

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

    LEDEX WL-070+ is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) summary document for K163605, a dental curing light, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and training/test sets for an AI/ML device cannot be extracted from this document. The document describes the FDA's clearance of a physical medical device (LEDEX WL070+) and confirms its substantial equivalence to a predicate device, based on its intended use as a visible curing unit for polymerization of dental light-cured materials.

    The provided text does not contain any details about the acceptance criteria or a study proving that an AI/ML device meets such criteria.

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