K212043 is an FDA 510(k) clearance for the TRAUS ENDO. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 24, 2022, 359 days after receiving the submission on June 30, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K212043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2021 |
| Decision Date | June 24, 2022 |
| Days to Decision | 359 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX - Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |