K210475 is an FDA 510(k) clearance for the EQ-M. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Meta Systems Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 21, 2022, 581 days after receiving the submission on February 17, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K210475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2021 |
| Decision Date | September 21, 2022 |
| Days to Decision | 581 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 |