K053178 is an FDA 510(k) clearance for the SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on February 1, 2006, 79 days after receiving the submission on November 14, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K053178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2005 |
| Decision Date | February 01, 2006 |
| Days to Decision | 79 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 |