SUPER PORCELAIN TI-22

• K Number: K992024
• Device Name: SUPER PORCELAIN TI-22
• Manufacturer: NORITAKE CO., INC.
• Date Cleared: 1999-08-27 ( 72 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.

Device Description

Super Porcelain TI-22 and Accessories

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental porcelain product (Super Porcelain TI-22), indicating that it has been deemed substantially equivalent to a predicate device. It discusses regulatory matters, marketing permissions, and general controls, but it does not include details about device performance, acceptance criteria, or any specific studies with sample sizes, ground truth establishment, or expert involvement.

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.