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510(k) Data Aggregation

    K Number
    K023545
    Device Name
    ULTRA-LITE 200E LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-12-30

    (69 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 200E LIGHT CURE UNIT

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

    THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) letter for a dental device, specifically a light cure unit. Based on the provided text, the document focuses on the regulatory aspects of the device's clearance and does NOT contain information about performance acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical studies with specific performance metrics as might be seen for novel or higher-risk devices.

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification and validation report, or a clinical study report.

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