K060275 is an FDA 510(k) clearance for the PIEZOTOME. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on May 3, 2006, 90 days after receiving the submission on February 2, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K060275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2006 |
| Decision Date | May 03, 2006 |
| Days to Decision | 90 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 |