Data / Medical devices / Mexico / Aligntech de Mexico S, de R. L. de C. V.

Aligntech de Mexico S, de R. L. de C. V.: FDA-registered device maker in Cd. Juarez Chihuahua, Mexico, 14 510(k) clearances

Name: Aligntech de Mexico S, de R. L. de C. V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aligntech de Mexico S, de R. L. de C. V. is registered with the FDA (registration 3012138716) in Cd. Juarez Chihuahua, Mexico. It lists 14 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 25, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012138716
Address: Avenida Intermex # 1357 Parque Industrial Intermex, Cd. Juarez Chihuahua, Mexico, 32575
Owner or operator: Align Technology, Inc. (9035576)
Roles: Manufacturer, Repackager or relabeler
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

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Repackager or relabeler	accessdata.fda.gov
Indirect Bonding Tray	QJJ	1	Manufacturer	accessdata.fda.gov
Intraoral Camera	QJK	2	Manufacturer	accessdata.fda.gov
Light Transmission Caries Detector	NTK	2	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Orthodontic Software	PNN	2	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	1	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 25, 2026	K262196	Invisalign System	PNN	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
July 2, 2026	K261847	iTero Lumina Pro	NTK	Substantially Equivalent	Align Technology , Ltd.	accessdata.fda.gov
October 23, 2025	K252931	Invisalign® Palatal Expander System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
October 9, 2025	K252870	Invisalign Specifix Attachment System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
August 29, 2025	K252380	Invisalign System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
August 16, 2024	K240573	iTero Lumina Pro	NTK	Substantially Equivalent	Align Technology , Ltd.	accessdata.fda.gov
June 18, 2024	K241412	Invisalign System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
December 15, 2023	K232887	Invisalign Palatal Expander System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
September 26, 2023	K232233	Invisalign System with Mandibular Advancement Featuring Occlusal Blocks	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
December 22, 2022	K222894	Invisalign System, Pre-Formed Attachment System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
April 7, 2022	K220287	Invisalign System	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
March 20, 2020	K193659	iTero Element 5D	NTK	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
October 26, 2018	K181739	Invisalign System with Mandibular Advancement Feature	NXC	Substantially Equivalent	Align Technology, Inc.	accessdata.fda.gov
September 8, 1998	K981095	ALIGN SYSTEM	NXC	Substantially Equivalent	Align Technology	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.