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510(k) Data Aggregation

    K Number
    K033435
    Device Name
    E-SARANG 86, DM78, DM55
    Manufacturer
    WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
    Date Cleared
    2003-11-12

    (15 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003603
    Why did this record match?
    Reference Devices :

    K003603

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

    Reconstruction of dental restorations.

    e-Sarang 86: Inlays for non stress-bearing areas.

    DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures.

    DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures

    Device Description

    e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for dental casting alloys and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting performance data from a clinical or analytical study with defined acceptance criteria.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

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