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K Number
K133211
Device Name
ZIRTOUGH
Manufacturer
KURARAY NORITAKE DENTAL INC.
Date Cleared
2014-03-20

(153 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ZirTough is used for fabricating the all-ceramic dental frameworks or FCZ (=Full Contour Zirconia) crowns and bridges.

Device Description

Not Found

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is a 510(k) clearance letter from the FDA for a dental product called ZirTough. The letter confirms that ZirTough is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or ground truth methods.

§ 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.