K223340 is an FDA 510(k) clearance for the EDS Calculus Softener TURBO CR. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on December 11, 2023, 405 days after receiving the submission on November 1, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K223340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2022 |
| Decision Date | December 11, 2023 |
| Days to Decision | 405 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 |