Company · San Jose, CA, United States
Align Technology, Ltd.
Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.
- Drug products (DIN)
- 0
- 0 authorized now
- Natural health products
- 0
- 0 active licences
- Medical device licences
- 25
- 21 active
- Notices of Compliance
- 0
Medical device licences
Active licences first, newest first.
| Name | Licence | Status | First licensed |
|---|---|---|---|
| ITERO LUMINA - PC CFG | 114235 | Issued (active) · Class 2 | |
| ITERO LUMINA PRO | 111757 | Issued (active) · Class 2 | |
| ITERO LUMINA PRO MOBILE | 111758 | Issued (active) · Class 2 | |
| ALIGN X-RAY INSIGHTS | 111638 | Issued (active) · Class 2 | |
| ITERO LUMINA | 109502 | Issued (active) · Class 2 | |
| ITERO LUMINA MOBILE | 109503 | Issued (active) · Class 2 | |
| VIRTUAL CARE 3.0 | 108174 | Issued (active) · Class 2 | |
| INVISALIGN SPECIFIX ATTACHMENT SYSTEM | 107726 | Issued (active) · Class 2 | |
| INVISALIGN UV SANITIZING CASE | 107195 | Issued (active) · Class 2 | |
| INVISALIGN PALATAL EXPANDER SYSTEM | 106947 | Issued (active) · Class 2 | |
| ITERO ELEMENT 5D PLUS MOBILE | 105894 | Issued (active) · Class 2 | |
| ITERO ELEMENT 2 PLUS MOBILE | 105895 | Issued (active) · Class 2 | |
| ITERO ELEMENT 5D PLUS | 105785 | Issued (active) · Class 2 | |
| ITERO ELEMENT 2 PLUS | 105777 | Issued (active) · Class 2 | |
| ITERO ELEMENT 5D LAPTOP CONFIGURATION | 102232 | Issued (active) · Class 2 | |
| ITERO ELEMENT 5D | 102233 | Issued (active) · Class 2 | |
| ITERO ELEMENT FLEX INTRA-ORAL SCANNER | 100976 | Issued (active) · Class 2 | |
| ITERO ELEMENT 2 INTRA-ORAL SCANNER | 100980 | Issued (active) · Class 2 | |
| ITERO ELEMENT INTRA-ORAL SCANNER | 100960 | Issued (active) · Class 2 | |
| RETAINERS | 75315 | Issued (active) · Class 2 | |
| INVISALIGN | 10404 | Issued (active) · Class 2 | |
| INVISALIGN ATTACHMENT KIT | 83192 | Discontinued at renewal · Class 3 | |
| INVISALIGN INTER-PROXIMAL REDUCTION KIT (IPR KIT) | 78580 | Discontinued at renewal · Class 2 | |
| INVISALIGN BUTTON KIT | 63365 | Discontinued at renewal · Class 2 | |
| INVISALIGN PONTIC KIT | 63330 | Discontinued at renewal · Class 2 |
Recalls and safety alerts that mention its products
Health Canada’s recall notices do not carry licence numbers, so these are matched by name. 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