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510(k) Data Aggregation

    K Number
    K043301
    Device Name
    GC TION GINGIVAL PROTECTOR
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2005-01-25

    (56 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC TION GINGIVAL PROTECTOR

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

    This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated, regarding the device "GC TiON GINGIVAL PROTECTOR." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

    The letter focuses on the regulatory classification and general provisions for marketing the device. The "Indications for Use" section simply states the intended purpose of the device: "This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching."

    Therefore, I cannot provide the requested information based on the input text. There is no mention of:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes, data provenance, or ground truth establishment for any test or training set.
    • Expert involvement or adjudication methods.
    • MRMC comparative effectiveness studies or standalone algorithm performance.

    To fulfill your request, you would need to provide a document that describes the performance testing and associated results for the GC TiON GINGIVAL PROTECTOR.

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