K203615 is an FDA 510(k) clearance for the Dental Scaler and Air Polisher. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on December 10, 2021, 365 days after receiving the submission on December 10, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K203615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | December 10, 2021 |
| Days to Decision | 365 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 |