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510(k) Data Aggregation

    K Number
    K041372
    Device Name
    SMARTLITE PS PEN-STYLE LED CURING LIGHT
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2004-06-24

    (31 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K031615,K982318
    Why did this record match?
    Device Name :

    SMARTLITE PS PEN-STYLE LED CURING LIGHT

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

    The SmartLite™ PS Pen-Style LED Curing Light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials.

    Device Description

    The SmartLite™ PS Pen-Style LED Curing Light is a cordless, battery-powered unit designed for curing VLC materials whose initiator systems are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The unit is based ion LED (light emitting diode) technology for light generation. The SmartLite™ PS Pen-Style LED Curing Light includes: A handpiece with control electronics and an inductively-recharged battery. A probe with a single LED at the tip. A base/recharger unit that plugs directly into main power. An optional eye shield.

    AI/ML Overview

    This 510(k) summary describes a dental curing light, a medical device that does not rely on AI/ML. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training data for AI/ML performance is not applicable to this document.

    The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, operation, and technological characteristics (wavelength range, light source). It does not contain information related to AI/ML software performance or clinical studies in the context of AI/ML.

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