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Align Technology B.V.

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 10Class II 5Class III 0

plus 54 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 9Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

14registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 3Class III 1

25 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

13active ARTG entries

Class I 8IIa 5

HKHong KongMDACS

6valid listings

Class II 6

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States54 registration records, 16 510(k), 0 PMA, 3 excluded

Brazil14 confirmed, 0 excluded

Saudi Arabia14 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Align Technology, Inc. · Align Technology AFAB Poland Sp. z o.o. · Align Technology de Costa Rica S.R.L · Align Technology, Ltd. · ALIGN TECHNOLOGY INC. · ALIGN TECHNOLOGY, LTD.

FDA 510(k) clearances by year

11998

12008

12013

12015

12018

12020

22022

22023

22024

32025

12026

FDA listed device types

showing 8 of 15

Intraoral Camera 1Light Transmission Caries Detector 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Orthodontic Software 1Aligner, Sequential 1Indirect Bonding Tray 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile 1Maintainer, Space Preformed, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261847	iTero Lumina Pro	2026-07-02
US	K252931	Invisalign® Palatal Expander System	2025-10-23
US	K252870	Invisalign Specifix Attachment System	2025-10-09
BR	80194750002	ALINHADORES DENTÁRIOS REMOVÍVEIS	Class I
BR	80194750008	Invisalign Lens	Class I
BR	80194750004	Alinhadores Ortodônticos Removíveis	Class I
SA	ME0000002687SFDAA00056	iTero Element 5D Plus	—
SA	ME0000002687SFDAA00058	iTero Element 5D Plus Mobile	—
CA	63330	INVISALIGN PONTIC KIT	Class II
CA	63365	INVISALIGN BUTTON KIT	Class II
CA	78580	INVISALIGN INTER-PROXIMAL REDUCTION KIT (IPR KIT)	Class II