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510(k) Data Aggregation

    K Number
    K071674

    Validate with FDA (Live)

    Device Name
    GC-ZIRCONIA
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2007-08-09

    (51 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GC - Zirconia is indicated for use as a substructure (framework) for a single tooth or bridge type restoration. Applications include both anterior and posterior locations.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental material called "GC-Zirconia." It does not contain information about acceptance criteria or a study proving device performance as would be found in a submission for an AI/ML powered medical device. The document simply confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input.

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