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    K Number
    K030206
    Device Name
    APEX 90
    Manufacturer
    WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
    Date Cleared
    2003-01-29

    (8 days)

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

    APEX 90

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

    Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.

    Device Description

    Apex90 is a dental gold alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of gold and platinum bearing gold color

    AI/ML Overview

    The provided document is a 510(k) submission for a dental alloy named Apex90, not an AI device. As such, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI medical devices, is not applicable to this submission.

    The Apex90 submission focuses on demonstrating substantial equivalence to a predicate device (Bio Herador SG) based on material composition, design, and intended use, rather than performance metrics of an AI algorithm. The document states: "Apex 90 has the same device characteristics as the predicate device. Material, design and use concept is similar." and "Apex 90 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." However, specific details of these "safety, performance, and product validations" are not provided in this summary.

    Therefore, I cannot provide the requested information for an AI device.

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