Medical device licence · 101762 · Class 3
DEEP CONICAL (DC) IMPLANTS AND ACCESSORIES
Yes: licensed in Canada
Licence status Issued (active); first licensed September 21, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101762
- Licence holder
- Southern Implants Pty Ltd.Irene, South Africa
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 21, 2018
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPACT CONICAL ABUTMENT
- COSMETIC ABUTMENT
- COVERSCREW
- CUSTOM ABUTMENT BASE, ENGAGING
- CYLINDRICAL DRILL FOR DC, DISPOSABLE
- CYLINDRICAL TAP HANDPIECE INSERT
- DC CYLINDRICAL IMPLANT
- DC TAPERED IMPLANT
- EQUATOR OVERDENTURE ABUTMENT
- GOLD ABUTMENT, ENGAGING
- GOLD ABUTMENT, NON-ENGAGING
- HEALING ABUTMENT
- HEXED TITANIUM SCREW
- PASSIVE ABUTMENT, ENGAGING
- PASSIVE ABUTMENT, NON-ENGAGING
- TAPERED DRILLS
- TITANIUM ABUTMENT BASE
- TITANIUM ABUTMENT, ENGAGING
- TITANIUM ABUTMENT, NON-ENGAGING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.