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510(k) Data Aggregation

    K Number
    K071010
    Manufacturer
    Date Cleared
    2007-08-24

    (137 days)

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

    TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS

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

    Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.

    Tizian Zr Blanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.

    Device Description

    Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian guarantees an easy and reliable treatment without the need for long-term cooling.

    Tizian Blanks are composed of tetragonal zirconium dioxide stabilized with yttrium oxide. They are available in different sizes and permit the production of ceramic crowns and bridges. The material is partially sintered and can be processed using copy milling as well as CAD/CAM procedures.

    AI/ML Overview

    This document is a 510(k) Premarket Notification summary for "Tizian Ceramic" and "Tizian Zr Blanks." It describes the materials and their intended use, and indicates FDA clearance. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

    Therefore, I cannot provide the requested table and information as the provided text lacks the necessary details. The document is primarily a regulatory submission for market clearance based on substantial equivalence to predicate devices, not a performance study report.

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