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510(k) Data Aggregation
(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 | < 0.35% |
| Fe2O3 | < 0.3% |
Study Proving Device Meets Acceptance Criteria:
Sirona performed a series of nonclinical tests to assess if the device is appropriate for its intended use. This included:
- Sintering tests coupled with bench mechanical testing: These tests were conducted to demonstrate that the mechanical properties of the device are appropriate.
- Crack damage inspection: To ensure the material integrity.
- Restoration fit: To evaluate the precision of the resulting dental restorations.
- Color suitability: To confirm aesthetic compatibility.
- Overall usability tests: To assess the practical application of the device.
The document states that the physical and chemical properties of the proposed device are "similar" to the predicate device (inCoris ZI, K062509) and that both devices meet ISO 6872:2008 ("Dentistry — Ceramic materials") and ISO 13356:2008 ("Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). The material is also biocompatible according to ISO 10993-1:2009.
The following information regarding AI/ML device evaluation criteria is not applicable to this submission, as the inCoris ZI is a dental material, not an AI/ML powered device.
- Sample sizes used for the test set and data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. (The "ground truth" for a material is its physical and chemical properties, measured objectively).
- The sample size for the training set: Not applicable (as this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
(15 days)
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.
Ask a specific question about this device
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