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K Number
K143439
Device Name
KATANA Zirconia
Manufacturer
KURARAY NORITAKE DENTAL, INC.
Date Cleared
2015-02-27

(87 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

KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the KATANA Zirconia device, a material used for dental restorations. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and regulations.

§ 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.