K240340 is an FDA 510(k) clearance for the Surgical Drive System (Model: ES70, ES90, E8). This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on July 18, 2024, 164 days after receiving the submission on February 5, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K240340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | July 18, 2024 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZI - Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |