Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009646999

FEI Number

3009646999

Entity Name

Align Technology, Ltd.

City/State/Country

Petach Tikva Central, IL

Establishment Address

1 Yitzhak Rabin Rd., Petach Tikva Central 4925110, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Align Technology, Inc. (Owner Number: 9035576)

Owner / Operator Contact Address

410 North Scottsdale Road, Suite 1300, Tempe, AZ 85281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082207

PMA Number

N/A

All Registered Proprietary Names

iTero Lumina Pro iTero Lumina Pro Mobile iTero Lumina Pro Wand Barrier Sleeves iTero Element 5D iTero Element 5D, Full barrier sleeve iTero Element 5D Plus Mobile iTero Element 5D Plus iTero Element 5D Laptop Configuration iTero Element 5D Imaging System, Certified Pre-owned Cadent Articulator Kit iTero Articulator Kit Cadent Articulator iTero Software iOC Scanner iTero Element Flex iTero Element iTero Element 2 Plus iTero Element 5D Plus Lite iTero Element, Certified Pre-owned iTero HD2.9 Scanner iTero Element 2 iTero Element 2 Plus Mobile iTero HDU Scanner iTero Element Flex, Certified Pre-owned iTero Lumina Scanner Sleeve iTero Lumina iTero Element Sleeve iTero Element Scanner Sleeve (LCI Configuration) iTero Lumina Mobile OrthoCAD iQ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJK	Intraoral Camera	Dental	Class 2	872.3661	2024-10-25
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2024-10-25
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2020-03-24
EJP	Articulators	Dental	Class 1	872.3150	2011-12-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-06-24
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2016-06-24
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2011-12-05
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2011-12-05
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2011-12-05
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2011-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Lifei Liu Business: Align Technology, Inc. Email: l_liu@aligntech.com Phone: (408) 4701000

Related Public Records

Same Entity

Align Technology, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007527669	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX
2953749	Align Technology, Inc.	San Jose, CA, US
3025237243	Align Technology AFAB Poland Sp. z o.o.	Wroclaw Dolnoslaskie, PL
3012138716	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX
3005695824	Align Technology de Costa Rica S.R.L	Belen Heredia, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Similar Registrations

Registration Number	Establishment Name	Location
1000113729	Denterprise International, Inc.	Ormond Beach, FL, US
3015729	A-dec, Inc.	Newberg, OR, US
3007527669	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX
3044464584	Clear Capture, LCC	Berkeley Lake, GA, US
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009646999. Last updated year: 2026. Please use registration number 3009646999 when referencing this establishment in official correspondence.