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510(k) Data Aggregation

    K Number
    K981257
    Device Name
    JELFINE-52 (CODE NAME RD-0901)
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    1998-08-13

    (129 days)

    Product Code
    EJS,ESS
    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

    Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.

    Device Description

    Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.

    AI/ML Overview

    The provided text is a 510(k) premarket notification FDA letter from 1998 for a dental alloy named JELFINE-52. This type of document is a regulatory approval for a medical device and does not contain information about a clinical study with acceptance criteria and device performance as typically understood for software AI/ML devices.

    The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer demonstrated that their new device is as safe and effective as another legally marketed device, and therefore does not require new efficacy studies.

    Therefore, I cannot fulfill your request for information on acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided document. The questions you've asked are typically relevant for AI/ML medical devices undergoing de novo or PMA pathways, or 510(k)s that include detailed performance studies, which is not the case here.

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