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510(k) Data Aggregation

    K Number
    K050920
    Device Name
    CZR PRESS LF STAINS
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2005-05-11

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CZR PRESS LF STAINS

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

    For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a dental porcelain product (CZR Press LF Stains), not a study report. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) is not present in the provided text.

    The document essentially states that the FDA has determined the device is substantially equivalent to legally marketed devices and can proceed to market, subject to various regulations. It does not contain any performance data or study results.

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