Medical device licence · 102233 · Class 2
ITERO ELEMENT 5D
Yes: licensed in Canada
Licence status Issued (active); first licensed January 4, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102233
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 4, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ITERO ELEMENT 5D
- ITERO ELEMENT 5D DENTAL IMAGING SYSTEM
- ITERO ELEMENT 5D SCANNER SLEEVES
- ITERO ELEMENT 5D SCANNING UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.