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510(k) Data Aggregation

    K Number
    K012303
    Device Name
    JEL-20
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    2001-08-22

    (33 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JEL-20

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

    This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges.

    Device Description

    Jel-20 is a white Type III Crown & Bridge alloy.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental alloy, stating its substantial equivalence to a predicate device. It does not include a scientific study report or clinical trial results. Therefore, I cannot fulfill your request based on this input.

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