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510(k) Data Aggregation

    K Number
    K020877
    Device Name
    EXCELLITE TURBO LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-06-12

    (86 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXCELLITE TURBO LIGHT CURE UNIT

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

    THE EXCELLITE TURBO IS A.LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

    Device Description

    EXCELLITE TURBO LIGHT CURE UNIT

    AI/ML Overview

    This looks like a 510(k) clearance letter for a dental light cure unit, not a study report for an AI device. The document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

    Specifically, the device is the "Excellite Turbo Light Cure Unit" and its indication for use is "for polymerization of light cured material by dental professionals." This is a physical device used for dental procedures, not an AI or software-as-a-medical-device (SaMD).

    Therefore, I cannot provide the requested information based on the provided text. The questions you've asked are relevant for AI/SaMD submissions, but not for this type of traditional medical device clearance.

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