K121114 is an FDA 510(k) clearance for the TIGRAN PERIBRUSH. This device is classified as a Scaler, Rotary (Class II - Special Controls, product code ELB).
Submitted by Tigran Technologies AB (Malmo, SE). The FDA issued a Cleared decision on September 17, 2012, 158 days after receiving the submission on April 12, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4840.
| 510(k) Number | K121114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2012 |
| Decision Date | September 17, 2012 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELB — Scaler, Rotary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4840 |