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510(k) Data Aggregation

    K Number
    K971574
    Device Name
    JELBOND-PDF
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    1997-05-20

    (43 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

    It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.

    Device Description

    It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure.

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the device "Jelbond-PdF". It does not contain any information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications.

    The letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to a legally marketed predicate device. This substantial equivalence determination allows the manufacturer to market the device.

    Therefore, I cannot provide the requested information based on the input text.

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