The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for T1/t2/t3 Turbine Family.
| Device ID | K131319 |
| 510k Number | K131319 |
| Device Name: | T1/T2/T3 TURBINE FAMILY |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2014-05-30 |
| Summary: | summary |