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Data / Medical devices / United States / Align Technology, Inc.

Align Technology, Inc.: FDA-registered device maker in San Jose, CA, United States, 14 510(k) clearances

Align Technology, Inc. is registered with the FDA (registration 2953749) in San Jose, CA, United States. It lists 14 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 25, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Align Technology, Inc.
FDA registration number
2953749
FEI number
3002519584
Address
2820 Orchard Parkway, San Jose, CA, United States, 95134
Owner or operator
Align Technology, Inc. (9035576)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
April 19, 2006
Registered through
2027
Brand names listed
3D Treatment Planning Software - ClinCheck Pro 6, Attachment Template, Cleaning Crystals, Packette, Gumlines, Invisalign ART, Invisalign Assist, Invisalign Cheek Retractor, Medium, Invisalign Detail Pliers and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Complaint file establishment, Specification developeraccessdata.fda.gov
Aligner, SequentialNXC2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Complaint file establishment, Specification developeraccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Complaint file establishment, Specification developeraccessdata.fda.gov
Indirect Bonding TrayQJJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Intraoral CameraQJK2Complaint file establishmentaccessdata.fda.gov
Light Transmission Caries DetectorNTK2Complaint file establishmentaccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Orthodontic SoftwarePNN2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Plier, OrthodonticJEX1Complaint file establishment, Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Complaint file establishment, Specification developeraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Complaint file establishmentaccessdata.fda.gov
Tray, Impression, PreformedEHY1Complaint file establishment, Specification developeraccessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileNOB1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 25, 2026K262196Invisalign SystemPNNSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
July 2, 2026K261847iTero Lumina™ ProNTKSubstantially EquivalentAlign Technology , Ltd.accessdata.fda.gov
October 23, 2025K252931Invisalign® Palatal Expander SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
October 9, 2025K252870Invisalign Specifix Attachment SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
August 29, 2025K252380Invisalign SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
August 16, 2024K240573iTero Lumina™ ProNTKSubstantially EquivalentAlign Technology , Ltd.accessdata.fda.gov
June 18, 2024K241412Invisalign SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
December 15, 2023K232887Invisalign Palatal Expander SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
September 26, 2023K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
December 22, 2022K222894Invisalign System, Pre-Formed Attachment SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
April 7, 2022K220287Invisalign SystemNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
March 20, 2020K193659iTero Element 5DNTKSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
October 26, 2018K181739Invisalign System with Mandibular Advancement FeatureNXCSubstantially EquivalentAlign Technology, Inc.accessdata.fda.gov
September 8, 1998K981095ALIGN SYSTEMNXCSubstantially EquivalentAlign Technologyaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 5, 202291320Class IICompletedInvisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 90013D 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.accessdata.fda.gov

Compare with other makers

Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.