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510(k) Data Aggregation

    K Number
    K143667
    Device Name
    GC KommonBase
    Manufacturer
    GC Orthodontics America Inc.
    Date Cleared
    2015-05-07

    (135 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fabricating resin base (understructure) for bracket placement

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "GC KommonBase." This letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria, study details, or performance data for the GC KommonBase device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance studies.

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