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510(k) Data Aggregation

    K Number
    K020874
    Device Name
    ULTRA-LITE 5 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 :

    ULTRA-LITE 5 TURBO LIGHT CURE UNIT

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

    THE ULTRA-LITE 5 TURBO IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental light cure unit. It confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.

    However, this document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or clinical performance data as you have requested. These details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

    Therefore, I cannot extract the information you are looking for from the given text.

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