Medical device licence · 110653 · Class 3
OMNITAPER
Yes: licensed in Canada
Licence status Issued (active); first licensed January 3, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110653
- Licence holder
- Dentsply Implants Manufacturing GmbhHanau, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 3, 2024
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMPLANT DRIVER TEMPBASE
- OMNITAPER CRESTAL DRILL
- OMNITAPER CRESTAL DRILL GS
- OMNITAPER DEPTH GAUGE
- OMNITAPER DIRECTION INDICATOR
- OMNITAPER DRILL
- OMNITAPER DRILL GS
- OMNITAPER DRILL SLEEVE FOR DRILL GS
- OMNITAPER DRILL SP
- OMNITAPER EV OSSEOSPEED
- OMNITAPER IMPLANT DRIVER TEMPBASE GS
- OMNITAPER INITIAL DRILL
- OMNITAPER MUCOSAL PUNCH
- OMNITAPER SLEEVE FOR IMPLANT DRIVER TEMPBASE GS
- OMNITAPER TAP
- OMNITAPER TAP GS
- OMNITAPER TRY-IN IMPLANT
- TEMPBASE CAP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.