K242317 is an FDA 510(k) clearance for the Integrated Endo System (Meet Endo-II). This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Denjoy Dental Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on February 13, 2025, 192 days after receiving the submission on August 5, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K242317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2024 |
| Decision Date | February 13, 2025 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC - Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |