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510(k) Data Aggregation

    K Number
    K020117
    Device Name
    GC FUJI LINING LC PASTE PAK
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2002-02-28

    (45 days)

    Product Code
    EMA,EJK
    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 Fuji Lining LC Paste Pak is intended to be used as a base or liner in prepared cavities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "GC Fuji LINING LC PASTE PAK" device. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

    The letter explicitly mentions that the device is a "Calcium Hydroxide Cavity Liner" intended to be used "as a base or liner in prepared cavities."

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or groundbreaking studies related to AI or human improvement.

    The letter is a regulatory approval document based on substantial equivalence to existing devices, not a scientific study report. Therefore, I cannot provide the requested information from this document.

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