K100647 is an FDA 510(k) clearance for the A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on July 9, 2010, 123 days after receiving the submission on March 8, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K100647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2010 |
| Decision Date | July 09, 2010 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |