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510(k) Data Aggregation

    K Number
    K011628
    Device Name
    CONCORD 82
    Manufacturer
    GATEWAY ALLOYS, INC.
    Date Cleared
    2001-07-16

    (48 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, granting clearance for a dental casting alloy named "Concord 82". It does not describe any acceptance criteria for a device, nor does it present any study data demonstrating the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance and testing data.

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