Medical device licence · 100118 · Class 3
TREFOIL 1.5
Yes: licensed in Canada
Licence status Issued (active); first licensed December 7, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100118
- Licence holder
- Nobel Biocare AbGoteborg, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 7, 2017
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BAR DISC TREFOIL
- CLINICAL SCREW TREFOIL
- GUIDE DRILL
- IMPLANT MOUNT
- ROUND ABUTMENT TREFOIL
- SCREW DISC TREFOIL
- SCREW TAP
- STABILIZING SCREW V-TEMPLATE TREFOIL
- TEMPORARY SCREW IMPLANT TREFOIL
- TRANSFER ABUTMENT TREFOIL
- TREFOIL BAR
- TREFOIL IMPLANT CC
- TWIST DRILL TREFOIL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.