K240801 is an FDA 510(k) clearance for the BioSonic US200 Ultrasonic Scaler (60034537). This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on July 1, 2024, 98 days after receiving the submission on March 25, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K240801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2024 |
| Decision Date | July 01, 2024 |
| Days to Decision | 98 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 |