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510(k) Data Aggregation
(124 days)
rainbow™ Trans is used in the manufacture of a dental core.
rainbow™ Trans is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Trans is milled into cores of artificial teeth and then is finally sintered in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
The provided document describes the predicate device and the new device (rainbow™ Trans) being submitted for 510(k) premarket notification. The study provided is a comparison of technical characteristics and performance data against established standards, rather than a clinical study involving human subjects or AI performance. Therefore, many of the requested categories (sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract the acceptance criteria and reported device performance from the "Performance Data" section.
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Item | Acceptance Criteria | Reported Device Performance | Standard |
|---|---|---|---|---|
| Biocompatibility Testing | ||||
| 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 | ||||
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size |
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