K210789 is an FDA 510(k) clearance for the EQ-PEX. This device is classified as a Locator, Root Apex.
Submitted by Meta Systems Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 20, 2021, 218 days after receiving the submission on March 16, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K210789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2021 |
| Decision Date | October 20, 2021 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQY — Locator, Root Apex |
| Device Class | — |