(66 days)
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals.
The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia.
They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese.
The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.
The provided document is a 510(k) Premarket Notification for a dental device, ArgenZ MTZ, which is a dental zirconia ceramic. It outlines the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
This document describes the device itself and its physical and chemical properties, but does not describe a study involving a human expert in the loop (e.g., radiologist) or an AI algorithm for diagnostic purposes. Therefore, many of the requested items related to AI/human performance studies are not applicable to the information contained in this document.
However, I can extract information related to the acceptance criteria for the device's physical and chemical properties and how those properties were tested.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a "Substantial Equivalence Comparison Table" that lists various physical and chemical properties and the device's performance against specified criteria, which effectively serve as acceptance criteria to demonstrate equivalence to the predicate device and compliance with ISO standards.
| Acceptance Criteria (Property) | Acceptance Standard / Predicate Performance | Reported Device Performance (ArgenZ MTZ) |
|---|---|---|
| Classification (per ISO 6872:2015) | Class 5 (Predicate) | Class 5 |
| Composition | Yttria-stabilized zirconia (5Y on top of 4Y - Predicate) | Based on yttria-stabilized zirconia, 5Y zirconia on top of 4Y zirconia |
| Color | Color (Predicate) | Color |
| Intended User | Professional dental technicians (Predicate) | Professional dental technicians |
| Single Use | Yes (Predicate) | Yes |
| Sterile | Non-sterile (Predicate) | Non-sterile |
| Physical Properties | Conform to ISO 6872:2015 (Predicate) | Conform to ISO 6872:2015 |
| Uniformity | Uniform (Predicate) | Uniform |
| Freedom from extraneous materials | Free from extraneous materials (Predicate) | Free from extraneous materials |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ (Predicate) | ≤ 1.0 Bq·g⁻¹ |
| Flexural strength | ≥ 800 MPa (Predicate: Multilayer-3Dpro) | ≥ 800 MPa |
| 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.