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510(k) Data Aggregation

    K Number
    K994048
    Device Name
    PORTABLE LIGHT CURING UNIT
    Manufacturer
    GREGORY S. JACOB, D.D.S.
    Date Cleared
    2000-01-13

    (48 days)

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

    This curing light unit is a source of illumination for the curing of dental restorative materials and is a source of illumination for tooth whitening materials used in dentistry.

    Device Description

    Portable Light Curing Unit

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a "Portable Light Curing Unit." It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-related details.

    Therefore, I cannot fulfill your request using the provided text. The document is strictly an FDA clearance letter confirming substantial equivalence to a predicate device.

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