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510(k) Data Aggregation
(101 days)
rainbow™ Shade is a pre-sintered zirconia(Y-TZP) block for fabrication of single-tooth and bridgework restoration.
rainbow™ Shade is a dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shade is milled into cores of teeth and then is fired in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
The provided text describes the performance data for a dental ceramic device named "rainbow™ Shade." It includes acceptance criteria and results from various tests, primarily focusing on biocompatibility and physical properties.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Here are the tables from the document, summarizing the acceptance criteria and the device's performance:
Biocompatibility Testing
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization (Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulus threshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemic toxicity | None acute Systemic toxicity | ISO 10993-11 |
| 5 | Genotoxicity | None genotoxicity | None genotoxicity | ISO 10993-3 |
Performance Bench Testing
| No. | Items | Criteria | Result | Standard |
|---|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size 800MPa). |
8. The sample size for the training set
This section is not applicable. The device is a physical material, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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