KATANA Zirconia Block

• K Number: K170986
• Device Name: KATANA Zirconia Block
• Manufacturer: Kuraray Noritake Dental Inc.
• Date Cleared: 2017-07-13 ( 101 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

The provided text is a clearance letter from the FDA for a dental device, KATANA Zirconia Block, and indications for its use. It describes the regulatory classification and general controls applicable to the device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other details requested in your prompt.

Therefore, I cannot provide the requested information based on the input text. The text does not describe a study or provide performance metrics for the device.

Regulation Number and Section

§ 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.