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510(k) Data Aggregation

    K Number
    K012849
    Device Name
    GLASS POST
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2002-03-27

    (236 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLASS POST

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

    The Glass Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental device (Glass Post) and does not contain information about acceptance criteria or a study proving device performance using AI. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail any performance studies, acceptance criteria, or AI-related evaluations. It is a regulatory approval, not a technical performance report.

    Therefore, I cannot provide the requested information based on the input text.

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