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K Number
K071010
Device Name
TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
Manufacturer
SCHUTZ-DENTAL GMBH
Date Cleared
2007-08-24

(137 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
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.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.