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510(k) Data Aggregation

    K Number
    K993973

    Validate with FDA (Live)

    Device Name
    FUJI II LC CAPSULE
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2000-01-11

    (49 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K052235
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Class III and V restorations; particularly areas of cervical erosion, a. abfraction lesions and root surface caries.
    • Restoration of primary teeth b.
    • As a base or liner C .
    • Core build-ups/block-outs (particularly of vital teeth) ర .
    • Cases in which a radiopaque restoration is required e .
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Fuji II LC Capsule, which is a dental material. It confirms that the device is substantially equivalent to a legally marketed predicate device and lists its indications for use.

    Therefore, I cannot extract any of the requested information regarding acceptance criteria or a study proving device performance from this document.

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