Medical device licence · 63365 · Class 2
INVISALIGN BUTTON KIT
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 4, 2003; ended October 22, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63365
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- December 4, 2003
- Ended
- October 22, 2015
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INVISALIGN BUTTON KIT
- INVISALIGN BUTTON KIT - ALIGNER POLISHING WHEEL
- INVISALIGN BUTTON KIT - BUR, INVISALIGN EZ TRIM
- INVISALIGN BUTTON KIT - BUTTONS
- INVISALIGN BUTTON KIT - CLEAR LOCK GEL
- INVISALIGN BUTTON KIT - COMPOSITE BUTTON BONDING
- INVISALIGN BUTTON KIT - ETCHANT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “invisalign”. A notice may cover another product or only some lots: read it to see what it covers.
- Invisalign System (2019-12-12)January 7, 2020 · Medical devices · Medical devices · Type III
- Invisalign System (2019-08-12)September 6, 2019 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.