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Sign in to claim this brandAlign Technology Ltd.
Israel·IL-MF-000000745
Last updated September 18, 2026
About
As I reflect on fiscal 2025, I am proud of how Align navigated a year that demanded focus, resilience, and disciplined execution. The operating environment remained uneven across regions, consumer demand was pressured in parts of the world, and we made difficult organizational decisions to better position the company for the future. Yet through these challenges, our teams stayed anchored to what matters most—serving doctors and their patients—and delivered a strong finish to the year.
From the manufacturer's own website. Source
What Align Technology Ltd. makes
Align Technology Ltd. manufactures intraoral scanners, scanning units, and associated service kits for dental applications, including the iTero Lumina Pro, iTero Element 5D Plus, and iTero Element Flex. These devices are designed for capturing digital impressions of teeth and oral structures, supporting orthodontic and restorative treatments. The company also produces replacement parts and configuration tools, such as scanning unit RMAs and interface boxes, to maintain and upgrade existing systems.
The company’s devices are classified under EU medical device regulations as Class I and Class IIa, with several listed in the EU’s eudamed database. These products are intended for use within the European Union’s regulatory framework, though specific authorisation status varies by device and jurisdiction. The manufacturer is based in Israel.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Israel
- Address
- 1, Yitzhak Rabin, Petach Tikva, Israel
- Website
- www.aligntech.com
- facebook.com/AlignTechInc
- [email protected]
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- IL-MF-000000745
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (84)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iTero Element Scanner Sleeve | 221963 | EUDAMED | Class IIa | Active |
| iTero Wheel Stand | 211384 | EUDAMEDFDA UDI | Class I | Active |
| iTero Lumina PC cfg Scanning Unit, RMA | 223166 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element 5D Laptop Configuration Upgrade Kit | 206856 | EUDAMEDFDA UDI | Class IIa | Active |
| iTero Plus Mobile Computing unit | 217591 | EUDAMEDFDA UDI | Class I | Active |
| iTero Plus Mobile Computing unit | 212275 | EUDAMED | Class I | Active |
| iTero Lumina Interface Box | 223060 | EUDAMED | Class I | Active |
| iTero Element Plus Wheel Stand, kit | 211563 | EUDAMEDFDA UDI | Class I | Active |
| iTero Lumina Mobile Configuration | 221962 | EUDAMED | Class I | Active |
| iTero Lumina PC cfg | 223101 | EUDAMED | Class I | Active |
| iTero Plus Mobile Computing unit | 217593 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element Scanner Sleeve | 109236 | EUDAMEDFDA UDI | Class IIa | Active |
| iTero Lumina Pro Mobile Upgrade | 221940 | EUDAMED | Class IIa | Active |
| iTero Lumina Pro Scanning Unit, RMA Package | 221955 | EUDAMED | Class IIa | Active |
| iTero Element 5D Plus | 211484 | EUDAMEDFDA UDI | Class IIa | Active |
| iTero Lumina PC cfg Scanning Unit, RMA | 223114 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element 2 Plus, mobile configuration | 217110 | EUDAMED | Class I | Active |
| iTero Element Flex | 202964 | EUDAMEDFDA UDI | Class I | Active |
| iTero Plus Computing unit | 212265 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element 5D Laptop Configuration | 207279 | EUDAMED | Class IIa | Active |
| iTero Lumina™ Pro Upgrade | 223074 | EUDAMED | Class IIa | Active |
| iTero Lumina Cart Configuration | 213782 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element 2 Plus | 211782 | EUDAMEDFDA UDI | Class I | Active |
| iTero Lumina PC cfg | 223111 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element Flex | 217106 | EUDAMED | Class I | Active |
| Gumlines | 226797 | EUDAMED | Class I | Active |
| iTero Lumina Pro intraoral scanning unit | 221909 | EUDAMED | Class IIa | Active |
| iTero Lumina Mobile Configuration | 213783 | EUDAMEDFDA UDI | Class I | Active |
| iTero Lumina™ Pro Mobile Upgrade | 223076 | EUDAMED | Class IIa | Active |
| iTero Element™ 2 Plus | 211889 | EUDAMEDFDA UDI | Class I | Active |
| iTero Element 2 | 212095 | EUDAMED | Class I | Active |
| iTero Element 5D Rental | 212096 | EUDAMED | Class IIa | Active |
| iTero Lumina - PC cfg intraoral scanning unit | 223112 | EUDAMEDFDA UDI | Class I | Active |
| iTero Plus Computing unit | 209865 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Align Technology Ltd. has one FDA recall record initiated on December 5, 2022, which is marked as completed. The recall pertains to a defect in its 3D orthodontic planning software, where the system may generate an incorrect number of aligners—either fewer or more than prescribed—and provide improper packaging.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 5, 2022 | Z-1017-2023 | — | completed | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided. |