Medical device licence · 106947 · Class 2
INVISALIGN PALATAL EXPANDER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 8, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106947
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 8, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INVISALIGN PALATAL EXPANDERS
- INVISALIGN PALATAL EXPANDERS WITH ENGAGEMENT FEATURES
- INVISALIGN PALATAL HOLDERS
- INVISALIGN PALATAL HOLDERS WITH ENGAGEMENT FEATURES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.