K232810 is an FDA 510(k) clearance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Micro-Nx Co., Ltd. (Dong-Gu, KR). The FDA issued a Cleared decision on November 9, 2023, 58 days after receiving the submission on September 12, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K232810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2023 |
| Decision Date | November 09, 2023 |
| Days to Decision | 58 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 |