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510(k) Data Aggregation

    K Number
    K973372
    Device Name
    AUROFILM 2000
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1997-11-26

    (79 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For Enhancement of Porcelain Bond and Color in Porcelain-Fused-to-Metal Dental Crowns and Bridges.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental device, specifically "Aurofilm 2000" for "Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The letter from the FDA to Metalor Dental USA Corporation confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications and general controls but does not delve into the specifics of a study proving the device meets performance acceptance criteria.

    Therefore, I cannot provide the requested information based on the given document.

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