LogoFDA 510(k) Search
K Number
K031968
Device Name
CERABIEN ZR
Manufacturer
NORITAKE CO., INC.
Date Cleared
2003-12-22

(179 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

For use in prosthetic dentistry to create an all-ceramic prosthesis

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a dental device called "Cerabien ZR," which is a porcelain powder for clinical use. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is an FDA clearance stating that the device is substantially equivalent to a legally marketed predicate device. It indicates that the device can be marketed subject to general controls and, if applicable, special controls.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance, not performance study details.

§ 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.