K213897 is an FDA 510(k) clearance for the Pro M Class. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Saeyang Microtech Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 19, 2022, 279 days after receiving the submission on December 14, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K213897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2021 |
| Decision Date | September 19, 2022 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| 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 |