CZR PRESS LF STAINS

• K Number: K050920
• Device Name: CZR PRESS LF STAINS
• Manufacturer: NORITAKE CO., INC.
• Date Cleared: 2005-05-11 ( 29 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a dental porcelain product (CZR Press LF Stains), not a study report. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) is not present in the provided text.

The document essentially states that the FDA has determined the device is substantially equivalent to legally marketed devices and can proceed to market, subject to various regulations. It does not contain any performance data or study results.

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.