(122 days)
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Standard BS EN ISO 6872:2015) | Criteria | Reported Performance (ArgenZ Liquids) |
|---|---|---|
| Flexural Strength | ||
| ArgenZ HT+ | >= 800 MPa | 1230 MPa |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | >= 800 MPa | 1223 MPa |
| ArgenZ Anterior | >= 500 MPa | 868 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | >= 500 MPa | 765 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | >= 500 MPa | 963 MPa |
| Chemical Solubility | ||
| ArgenZ HT+ |
§ 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.