K091331 is an FDA 510(k) clearance for the PIEZOTOME 2. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on December 11, 2009, 220 days after receiving the submission on May 5, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K091331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2009 |
| Decision Date | December 11, 2009 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZI — Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |