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K Number
K190079
Device Name
ArgenZ HT+
Manufacturer
The Argen Corporation
Date Cleared
2019-04-12

(86 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K071410,K180252
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

Device Description

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

AI/ML Overview
  1. Acceptance Criteria and Reported Device Performance
Acceptance Criteria (from BS EN ISO 6872:2015 via predicate device or standard)Reported Device Performance (ArgenZ HT+)
Flexural strength: ≥ 800 MPa1348 MPa (ArgenZ HT+ unshaded)
1172 MPa (ArgenZ HT+ Shade A4)
1143 MPa (ArgenZ HT+ Shade OM1)
Chemical solubility:

§ 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.