(131 days)
Classic sintering
- Framework and reduced crowns in the anterior and posterior tooth region
- Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics
- Crown caps in the anterior and posterior region
- Cone and telescoping crowns
Speed sintering
- Framework and reduced crowns in the anterior and posterior tooth region
- Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 units
- Crown caps in the anterior and posterior region
- Cone and telescoping crowns
Super speed sintering
- Framework and reduced crowns with a maximum wall-thickness of 2 mm
The inCoris ZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The blocks are available in different colors.
The Sirona Dental Systems inCoris ZI is a dental ceramic block made of zirconia (ZrO2) used to grind custom dental restorations. The device is a material, not an AI/ML device, and therefore the standard AI/ML evaluation metrics are not applicable.
Here's a breakdown of the provided information:
Acceptance Criteria and Device Performance (Physical and Chemical Properties)
| Acceptance Criteria (Target) | Reported Device Performance (inCoris ZI) |
|---|---|
| Physical Properties | |
| Density | $\geq$ 6.05 g cm-3 |
| Thermal expansion coefficient (20 - 500 °C) | 11.0 10-6 K-1 |
| Bending strength | > 1100 MPa |
| Chemical Properties | |
| ZrO2+HfO2+Y2O3 | ≥ 99.0% |
| Y2O3 | 5.2% |
| HfO2 | 2% |
| Al2O3 |
§ 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.