K170596 is an FDA 510(k) clearance for the TN-Brush. This device is classified as a Scaler, Rotary (Class II - Special Controls, product code ELB).
Submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 11, 2017, 195 days after receiving the submission on February 28, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4840.
| 510(k) Number | K170596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2017 |
| Decision Date | September 11, 2017 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELB - Scaler, Rotary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4840 |