Medical device licence · 86546 · Class 3
DENTOALVEOLAR BONE FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86546
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 7, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI CORTEX SCREW COARSE PITCH SELF-TAPPING WITH PLUSDRIVE
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI CORTEX SCREW SELF-DRILLING WITH PLUSDRIVE RECESS
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI CORTEX SCREW SELF-TAPPING WITH PLUSDRIVE RECESS
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI EMERGENCY SCREW WITH PLUSDRIVE RECESS
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI MESH SCREEN
- DENTOALVEOLAR BONE FIXATION SYSTEM - TI PLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.