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510(k) Data Aggregation

    K Number
    K013506
    Device Name
    YELLOW SPECIAL
    Manufacturer
    METALOR TECHNOLOGIES USA
    Date Cleared
    2002-01-03

    (73 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, the results of a study, or any details related to device performance in the context of a clinical or analytical study. The document is an FDA 510(k) clearance letter for a dental device named "Yellow Special," indicating that it has been found substantially equivalent to a predicate device. It lists the device name, regulation number, product code, and indications for use, but no performance data, study design, or acceptance criteria are discussed.

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