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510(k) Data Aggregation
(279 days)
Bright Low Flow
- Class I, III, V (non-stress area, minimally invasive restoration)
- Composite resin repair
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
This document is a 510(k) summary for the medical device "Bright Low Flow", a light-cured flowable composite resin manufactured by GENOSS Co., Ltd. It declares that the device is substantially equivalent to a predicate device (K091388 G-aenial Universal Flo) and provides performance data to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two tables related to performance criteria: Biocompatibility and Performance Bench Testing.
Biocompatibility Acceptance Criteria and Performance:
| No. | Test | Method | Acceptance criteria | P/F (Result) |
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | None cytotoxicity | Pass |
| 2 | Irritation | ISO 10993-10 | None oral irritation | Pass |
| 3 | Sensitization | ISO 10993-10 | None sensitization | Pass |
| 4 | Acute systemic toxicity | ISO 10993-11 | None systemic toxicity | Pass |
| 5 | Genotoxicity | ISO 10993-3 | None genotoxicity | Pass |
| 6 | Implantation | ISO 10993-6 | Biocompatible | Pass |
| 7 | Chronic toxicity | ISO 10993-11 | No chronic toxicity | Pass |
Performance Bench Testing Acceptance Criteria and Performance:
| No. | Items | Method | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1 | Visual | ISO 4049 | No impurities and No specific changes | No impurities and No specific changes |
| 2 | Capacity | ISO 4049 | Capacity error of; Standard Capacity |
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