Align Technology
Publicly traded manufacturer of the Invisalign clear dental aligner system and intraoral scanners.
Updated Jul 1, 2026
Headquartered in Tempe, Arizona, United States
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Overview
About Align Technology
Align Technology is headquartered in Tempe, Arizona, and publicly traded on the Nasdaq. It manufactures the Invisalign clear aligner system and iTero intraoral scanners used by orthodontists and dentists in more than 100 countries.
Products
- Clear dental aligners (Invisalign)
- iTero intraoral scanners
- Digital treatment-planning software
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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EU MDR
The EU regulation that defines medical device requirements — CE Marking is the certification mark it produces once satisfied.
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Related
Regulatory Pathways
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