LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020158
    Device Name
    NON-EUGENOL TEMPORARY CEMENT
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2002-03-07

    (49 days)

    Product Code
    EMB,EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NON-EUGENOL TEMPORARY CEMENT

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

    for cementing temporary crowns, bridges, and other restorations as well as for trial cementing permanent restorations

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental cement device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML medical device. The letter confirms that the device, "NON-EUGENOL TEMPORARY CEMENT," is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and not a software-driven or AI-enabled device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1