Medical device licence · 98178 · Class 3
DENTAL FIXTURE - TS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 6, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98178
- Licence holder
- Osstem Implant Co., LtdBusan, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 6, 2016
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSSTEM IMPLANT COVER SCREW
- OSSTEM IMPLANT CUSTOM HEALING ABUTMENT
- OSSTEM IMPLANT TS HEALING ABUTMENT
- TS SCAN HEALING ABUTMENT
- TSII SA IMPLANT
- TSIII SA IMPLANT
- TSIII SA ULTRA-WIDE IMPLANT
- TSIV SA IMPLANT
- TSIV SA ULTRA-WIDE IMPLANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.