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510(k) Data Aggregation

    K Number
    K981461
    Device Name
    GC FUJI ORTHO LC
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    1998-06-25

    (63 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC FUJI ORTHO LC

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

    GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.

    Device Description

    GC Fuji Ortho LC is a glass ionomer dental cement.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a dental cement. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically found in a performance study report for an AI/ML device. Therefore, I cannot extract the requested information from this document.

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