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510(k) Data Aggregation

    K Number
    K033279
    Manufacturer
    Date Cleared
    2004-01-15

    (97 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GOLD DENTAL CASTING ALLOYS

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

    BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations
    Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations
    Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations
    PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations
    Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations
    PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations
    Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations
    Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations
    Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations

    Device Description

    Gold Dental Casting Alloys

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a series of FDA 510(k) forms for various dental casting alloys, primarily indicating their names and intended uses. It confirms that these devices have been found substantially equivalent to predicate devices. There is no mention of any clinical trials, performance metrics, or study designs in the given text.

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