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510(k) Data Aggregation

    K Number
    K994028

    Validate with FDA (Live)

    Device Name
    FLIPO XENON CURING LIGHT
    Manufacturer
    LOKKI
    Date Cleared
    2000-01-12

    (47 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flipo Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The document is a 510(k) clearance letter from the FDA for a dental curing light, confirming its substantial equivalence to a predicate device for its indicated use. It does not include any performance study data or a description of such studies.

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