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Align 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
LinkedIn: linkedin.com/company/align-technology
Facebook: facebook.com/AlignTechInc
Email: [email protected]
Phone: —
PRRC Contact: —
EUDAMED SRN: IL-MF-000000745
FDA FEI Number: —
DUNS Number: —

Catalogue (84)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
iTero Lumina DOA Kit, cart	213356	EUDAMEDFDA UDI	Class I	Active
iTero Lumina Scanning Unit RMA	216498	EUDAMED	Class I	Active
iTero Lumina Pro	221907	EUDAMED	Class IIa	Active
iTero Element™ 5D Plus DOA service kit	212269	EUDAMEDFDA UDI	Class IIa	Active
iTero Lumina Pro Scanning Unit, RMA	222048	EUDAMED	Class IIa	Active
iTero Lumina Interface Box	217622	EUDAMEDFDA UDI	Class I	Active
iTero Element 2 Plus	217105	EUDAMED	Class I	Active
iTero Element 5D Upgrade Kit	206855	EUDAMEDFDA UDI	Class IIa	Active
iTero Lumina Scanning Unit	222100	EUDAMEDFDA UDI	Class I	Active
iTero Lumina PC cfg	223110	EUDAMEDFDA UDI	Class I	Active
Packed Panel PC ASSY, 5D iTero Element, RMA	206954	EUDAMED	Class IIa	Active
iTero Element Flex	212094	EUDAMED	Class I	Active
iTero Lumina Scanning Unit	214500	EUDAMEDFDA UDI	Class I	Active
iTero Element 2	218556	EUDAMED	Class I	Active
iTero Element 2 Plus Mobile configuration	211490	EUDAMEDFDA UDI	Class I	Active
iTero Element 5D	218557	EUDAMED	Class IIa	Active
iTero Element 5D DOA Kit	206517	EUDAMED	Class IIa	Active
iTero Element 5D Plus	217102	EUDAMED	Class IIa	Active
iTero Lumina Scanning Unit RMA Configuration	213355	EUDAMEDFDA UDI	Class I	Active
iTero Lumina PC cfg Scanning Unit, RMA	223167	EUDAMED	Class I	Active
iTero Plus Mobile Computing unit	212273	EUDAMED	Class I	Active
iTero Plus Computing unit	217592	EUDAMED	Class I	Active
iTero Lumina - PC cfg intraoral scanning unit	223102	EUDAMED	Class I	Active
iTero Element 2	202965	EUDAMEDFDA UDI	Class I	Active
iTero Element 5D Plus Mobile Configuration	211491	EUDAMEDFDA UDI	Class IIa	Active
iTero Element 2 Plus	211483	EUDAMEDFDA UDI	Class I	Active
iTero Lumina Software	225969	EUDAMEDFDA UDI	Class I	Active
iTero Lumina PC cfg Scanning Unit, RMA	223115	EUDAMED	Class I	Active
iTero Element 2 DOA	202933	EUDAMED	Class I	Active
iTero Lumina Mobile upgrade from Element Plus	213341	EUDAMEDFDA UDI	Class I	Active
iTero Element 5D Plus mobile configuration	217604	EUDAMED	Class IIa	Active
iTero Element 5D Laptop Configuration	206160	EUDAMEDFDA UDI	Class IIa	Active
iTero Element™ 5D imaging system, Certified Pre-owned	217617	EUDAMED	Class IIa	Active
iTero Element 5D scanning unit, RMA	206955	EUDAMED	Class IIa	Active
iTero Plus Mobile Computing unit	209875	EUDAMEDFDA UDI	Class I	Active
iTero Lumina Pro Software	225979	EUDAMEDFDA UDI	Class IIa	Active
iTero Plus Computing unit	217590	EUDAMEDFDA UDI	Class I	Active
iTero Element™ 5D Plus	212260	EUDAMEDFDA UDI	Class IIa	Active
iTero Lumina Pro Upgrade	221949	EUDAMED	Class IIa	Active
iTero Scanning Unit Lumina	222984	EUDAMED	Class I	Active
E5D Plus Scanning Unit	211783	EUDAMEDFDA UDI	Class IIa	Active
iTero Lumina PC cfg Scanning Unit, RMA Package	223126	EUDAMED	Class I	Active
iTero Lumina Pro Mobile	217612	EUDAMED	Class IIa	Active
iTero Lumina Pro Scanning Unit, RMA Package	221956	EUDAMED	Class IIa	Active
iTero Element 5D	205929	EUDAMEDFDA UDI	Class IIa	Active
iTero Lumina Cart upgrade from Element Plus	213340	EUDAMEDFDA UDI	Class I	Active
iTero Lumina Scanner Sleeve	215470	EUDAMEDFDA UDI	Class I	Active
iTero Element 2 Plus DOA Service Kit	211789	EUDAMEDFDA UDI	Class I	Active
iTero Plus Computing unit	211385	EUDAMEDFDA UDI	Class I	Active
iTero Plus Mobile Computing unit	212266	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Align Technology B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.