Medical device licence · 101651 · Class 2
DENTAL HANDPIECE COMPONENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 21, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101651
- Licence holder
- Sirona Dental Systems GmbhBensheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 21, 2018
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 4-HOLE COUPLER, S-STYLE
- 5-HOLE COUPLER, K-STYLE
- 5-HOLE COUPLER, MIDWEST STYLE
- 5-HOLE COUPLER, S-STYLE
- 6-PIN COUPLER, MIDWEST STYLE
- 6-PIN LED COUPLER, S-STYLE
- MIDWEST KS6 K-STYLE COUPLER 6-PIN LED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.