K053555 is an FDA 510(k) clearance for the ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on August 21, 2006, 244 days after receiving the submission on December 20, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K053555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2005 |
| Decision Date | August 21, 2006 |
| Days to Decision | 244 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 |