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K Number
K071674
Device Name
GC-ZIRCONIA
Manufacturer
GC AMERICA, INC.
Date Cleared
2007-08-09

(51 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

GC - Zirconia is indicated for use as a substructure (framework) for a single tooth or bridge type restoration. Applications include both anterior and posterior locations.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental material called "GC-Zirconia." It does not contain information about acceptance criteria or a study proving device performance as would be found in a submission for an AI/ML powered medical device. The document simply confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

§ 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.