K Number
K984427
Manufacturer
Date Cleared
1999-03-15

(94 days)

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

FOR USE IN THE MANUFACTURE OF METAL-CERAMIC RESTORATIONS.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Excelsior Porcelain System. It does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications for a medical device study.

Therefore, I cannot fulfill your request using the provided information. The text is purely a regulatory approval document and lacks the technical details of a performance study.

§ 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.