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510(k) Data Aggregation

    K Number
    K061535
    Device Name
    GC XLC-100 CAPSULE
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2006-07-14

    (42 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations.

    Device Description

    GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental cement product, not a study report for an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

    The document discusses:

    • The trade/device name: GC XLC-100 Capsule
    • Regulation Number: 21 CFR 872.3275(b)
    • Regulation Name: Dental Cement
    • Regulatory Class: II
    • The FDA's determination of substantial equivalence to a legally marketed predicate device.
    • Indications for Use: "GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations."

    None of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is present in this regulatory letter as it pertains to a traditional medical device, not an AI/ML product.

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