(595 days)
METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC.
The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.
Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis.
Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG.
The provided text describes the 510(k) summary for the Z-CAD® Smile device, which is a dental ceramic blank used for prosthetic restorations. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed acceptance criteria and performance data in a traditional clinical trial format.
However, I can extract the relevant information regarding performance testing and acceptance criteria for the physical properties of the device as presented, and address the other points based on the available text.
Acceptance Criteria and Device Performance Study for Z-CAD® Smile
The Z-CAD® Smile device is a dental ceramic blank. The performance data presented focuses on physical and biocompatibility properties, demonstrating its safety and effectiveness by comparison to a predicate device and established standards.
1. Table of Acceptance Criteria and Reported Device Performance (Physical Properties):
| Physical Property | Units | Z-CAD® Smile Acceptance Criteria | Reported Z-CAD® Smile Performance | Primary Predicate Device Performance | Testing Method |
|---|---|---|---|---|---|
| Bending strength (biaxial) | MPa | $\ge 500$ | 610 | > 500 | ASTM C1161 |
| Solubility (acetic acid) | µg/cm$^2$ | $\le 100$ | $\le 50$ |
§ 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.