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510(k) Data Aggregation
(131 days)
INCORIS ZI
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 |
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(15 days)
INCORIS ZI
inCoris ZI are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Substructures of inCoris ZI are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the InCoris ZI device, which is a porcelain powder for clinical use as a substructure for dental restorations. This document is a regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The input text is a bureaucratic letter of approval, not a scientific study report.
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