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K Number
K983470
Device Name
SUPER PORCELAIN STAIN- PURE WHITE
Manufacturer
NORITAKE CO., INC.
Date Cleared
1998-12-22

(82 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .

Device Description

SUPER PORCELAIN STAIN - PURE WHITE

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Super Porcelain Stain - Pure White" device. It is not a study report and does not contain information about acceptance criteria or performance studies.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a device evaluation report.

§ 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.