Medical device licence · 107702 · Class 3
PRIMETAPER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 29, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107702
- Licence holder
- Dentsply Implants Manufacturing GmbhHanau, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 29, 2022
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GUIDE FIXATION DRILL GS
- GUIDE FIXATION SCREW GS
- INITIAL DRILL
- MUCOSAL PUNCH
- PRIMETAPER CORTICAL DRILL
- PRIMETAPER DIRECTION INDICATOR
- PRIMETAPER DRILL
- PRIMETAPER DRILL GS
- PRIMETAPER DRILL LONG
- PRIMETAPER DRILL SHORT
- PRIMETAPER DRILL SLEEVE
- PRIMETAPER EV OSSEOSPEED
- PRIMETAPER SLEEVE GS
- PRIMETAPER TAP
- PRIMETAPER TAP GS
- PRIMETAPER/ASTRA TECH IMPLANT DEPTH GAUGE
- TABILIZATION ABUTMENT EV
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.