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K Number
K131534
Device Name
KATANA ZIRCONIA
Manufacturer
KURARAY NORITAKE DENTAL INC.
Date Cleared
2013-10-11

(135 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 fabricating the all-ceramic dental frameworks or FCZ crowns and bridges.

This disc (or block) is designed to provide patients with strong and tough prosthetic dental restorations for anterior and posterior applications.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "KATANA Zirconia." It confirms that the device has been found substantially equivalent to a predicate device for its intended use.

The letter does not provide details about a study with acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. This is a regulatory clearance document, not a clinical study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms market clearance but does not contain the specific study details you've asked for.

§ 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.