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510(k) Data Aggregation

    K Number
    K012341
    Device Name
    TRANSLUX ENERGY
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2001-08-30

    (37 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K892456
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.

    Device Description

    Translux Energy Light Curing Unit which is classified as an Ultraviolet Activator for Polymerization (21C.F.R. § 872.607). Translux® Energy has the same intended use and is substantially equivalent to Kulzer's already 510(K)-cleared light-curing unit Translux® EC [K892456]. The Translux ® Energy is a further development of the Translux® EC light source to provide the patient and user with more comfortable handling and more favorable properties.

    AI/ML Overview

    The provided document is a 510(k) summary for the Heraeus Kulzer, Inc. Translux® Energy light-curing unit. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer the requested questions. This document is a regulatory submission, not a scientific study report.

    Therefore, I cannot extract the information required for the table and points 2-9 from the provided text.

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