Sirona Dental Systems GmbH
DE-MF-000000029 · Germany · Bensheim
Sirona Dental Systems GmbH is registered in the European database on medical devices as a manufacturer, with 116 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 80 |
|---|---|
| Class IIa | 36 |
Among these devices, 79 are declared implantable, 13 active, 2 with a measuring function.
Devices declared under this manufacturer
- Abutment Screw AT TX 3.5/4.0
- Abutment Screw AT TX 4.5/5.0
- Abutment Screw NB A 4.5
- Abutment Screw S SO 4.8, 6.5
- Energo Prophy
- Midwest Stylus® Plus SPK
- Midwest Tradition® Pro TCF
- TiBase AT EV 3.0 GH3 S
- TiBase B O 4.1 L
- TiBase NB RS 3.5 L
- TiBase NB RS 4.3 L
- TiBase S BL 4.1 L
Showing 12 of 116 declared devices.
Catalogue references include 6282474, 6282482, 6282565, 6460484, 6544360, 6598077.
European nomenclature codes declared: P01020180, Z12110180, Q010207, Z12110199, Q010280, Z12110101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Sirona Dental Systems GmbH (DE) · FDA 9681851 |
| Devices in EUDAMED | 116 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIRONA DENTAL SYSTEMS GMBH |
What it holds in Canada
| Licences on record | 34 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 29 |
| Class 3 devices | 5 |
| First licensed | 1999-09-03 |
Licence types: Device Family (20), System (8), Device Group Family (6).
Licensed under: TIBASE, ORTHOPHOS DENTAL X-RAY UNITS, SIDEXIS, DENTAL TURBINES, DENTAL MOTORS, SIROTOM SPARE ELECTRODES.
North American profile: Both markets. Sirona Dental Systems GmbH is registered in both the United States and Canada.