LogoFDA 510(k) Search
K Number
K983247
Device Name
SUPER PORCELAIN ADDMATE
Manufacturer
NORITAKE CO., INC.
Date Cleared
1998-11-03

(48 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
Dental
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

Not Found

AI/ML Overview

I'm sorry, but without further context, the provided document does not contain information on the acceptance criteria or a study proving that a device meets those criteria. The document appears to be an FDA 510(k) clearance letter for a dental device called "SUPER PORCELAIN ADDMATE", indicating it has been found substantially equivalent to a predicate device. It specifies general information about the clearance process but does not detail performance acceptance criteria or a specific study to validate them.

§ 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.