LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020884
    Device Name
    EXCELLITE 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 LIGHT CURE UNIT

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental light cure unit. It is not a study report or a document describing the acceptance criteria and performance of a device based on a study.

    Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) because this document does not contain that level of detailed study information.

    The letter primarily confirms that the "Excellite Light Cure Unit" is substantially equivalent to legally marketed predicate devices. It states its intended use for "polymerization of light cured material by dental professionals" but does not provide any performance metrics or study specifics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1