Medical device licence · 10404 · Class 2
INVISALIGN
Yes: licensed in Canada
Licence status Issued (active); first licensed September 7, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10404
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 7, 1999
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTEGRATED BUTTON
- INVISALIGN
- INVISALIGN ASSIST ALIGNER
- INVISALIGN ASSIST WARRANTY ALIGNER
- INVISALIGN FIRST-COMPREHENSIVE
- INVISALIGN GO
- INVISALIGN LITE
- INVISALIGN SYSTEM - LITE
- INVISALIGN SYSTEM - TEEN PACKAGE
- INVISALIGN SYSTEM-COMPREHENSIVE
- INVISALIGN SYSTEM-COMPREHENSIVE PHASE 2
- INVISALIGN SYSTEM-EXPRESS
- INVISALIGN SYSTEM-MODERATE
- INVISALIGN TEEN ALIGNER
- INVISALIGN TOUCH-UP
- MANDIBULAR ADVANCEMENT - ENHANCED PRECISION WINGS
- MANDIBULAR ADVANCEMENT - OCCLUSAL BLOCKS
- MANDIBULAR ADVANCEMENT - PRECISION WINGS
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.