Medical device licence · 100573 · Class 3
ASTRA TECH IMPLANT SYSTEM EV
Yes: licensed in Canada
Licence status Issued (active); first licensed February 15, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100573
- Licence holder
- Dentsply Implants Manufacturing GmbhHanau, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 15, 2018
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BONE REAMER EV
- BONE REAMER GUIDE EV
- CONOMETRIC ABUTMENT EV
- DIRECTION INDICATOR EV
- EV-STABILIZATION ABUTMENT
- IMPLANT DEPTH GAUGE EV
- MULTIBASE ABUTMENT EV
- MULTIBASE EV ABUTMENT HEAD WITH HOLDER
- MULTIBASE EV BRIDGE SCREW
- MULTIBASE EV HEAL CAP
- MULTIBASE EV TEMPORARY CYLINDER
- MULTIBASE SEMI-BURNOUT CYLINDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.