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510(k) Data Aggregation

    K Number
    K051780
    Device Name
    JETLITE 5000
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2005-07-28

    (27 days)

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

    JETLITE 5000

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

    The Jetlite 5000 is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by transmission of light through a rod.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Jetlite 5000", which is an Ultraviolet Activator for Polymerization. It acknowledges the substantial equivalence of the device to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance results, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document is merely a regulatory clearance and does not contain the technical study details you are asking for.

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