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K Number
K982129
Device Name
ANTAGON PORCELAIN
Manufacturer
EUROPEAN DENTAL IMPORTS, INC.
Date Cleared
1998-08-04

(48 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

Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.

Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.

After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Device Description

Antagon Porcelain

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification FDA letter which is a regulatory document. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request 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.