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    K Number
    K250009
    Device Name
    LED Curing Light (C01-X, C02-X)
    Manufacturer
    Premium Plus (Dongguan) Limited
    Date Cleared
    2025-04-10

    (98 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K153514,K221194
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    Device Name :

    LED Curing Light (C01-X, C02-X)

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

    LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.

    Device Description

    LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.

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