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510(k) Data Aggregation

    K Number
    K992024
    Device Name
    SUPER PORCELAIN TI-22
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1999-08-27

    (72 days)

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

    SUPER PORCELAIN TI-22

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

    For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.

    Device Description

    Super Porcelain TI-22 and Accessories

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental porcelain product (Super Porcelain TI-22), indicating that it has been deemed substantially equivalent to a predicate device. It discusses regulatory matters, marketing permissions, and general controls, but it does not include details about device performance, acceptance criteria, or any specific studies with sample sizes, ground truth establishment, or expert involvement.

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