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510(k) Data Aggregation
(182 days)
rainbow LS Block
rainbow™ LS Block can be used for manufacturing Crown, Veneer, Inlay and Onlay.
rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.
The provided information describes the acceptance criteria and performance data for a dental ceramic device named "rainbow™ LS Block," submitted for 510(k) premarket notification. The study primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device (IPS e.max CAD).
Here's the breakdown of the information that can be extracted from the document, organized according to your requested points.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing the performance data, including criteria and results, primarily from bench testing and biocompatibility.
| No. | Items | Criteria | Reported Device Performance (Result) | 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 (Ames, Micronucleus) | 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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