Dental Device Guide
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Manufacturer registered with FDA

Align Technology, Inc.

Tempe, AZ, United States. Lists 14 dental device types with FDA across 6 registered establishments, and holds 16 510(k) clearances as applicant.

FDA owner/operator9035576ManufacturerRepacker / relabelerSpecification developer11 clearances in five years
Device types listed
14
Brands and models
119
510(k) clearances
161998–2026
Markets registered in
17317 registrations outside the US
Establishments
6Costa Rica, Israel, Mexico +2
1998: 12008: 12015: 12018: 12020: 12022: 22023: 22024: 22025: 32026: 21990200020102020

510(k) clearances per year, 1990–2026

Registered in 17 markets

Where regulators' registries name Align Technology, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 14 device types listedCanada: 125 registrationsEuropean Union: 30 registrationsUnited Kingdom: 30 registrationsIsrael: 28 registrationsTaiwan: 21 registrationsAustralia: 16 registrationsBrazil: 13 registrationsSerbia: 13 registrationsCosta Rica: 10 registrationsHong Kong: 8 registrationsSouth Korea: 8 registrationsPeru: 7 registrationsChina: 3 registrationsColombia: 2 registrationsSaudi Arabia: 2 registrationsJapan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAlign Technology, Inc.16 clearances1998–2026Below
CanadaHealth CanadaRegistration holderALIGN TECHNOLOGY, LTD.ALIGN TECHNOLOGY INC.1251999–2026Pure Global AI
European UnionEUDAMEDRegistration holderAlign Technology Ltd.Align Technology Inc.30—Pure Global AI
United KingdomMHRAManufacturerAlign Technology Ltd.Align Technology Inc.30—Pure Global AI
IsraelAMARRegistration holderAlign Technology Ltd.Align Technology Inc. · Align Technology Inc28—Pure Global AI
TaiwanTFDAManufacturerAlign Technology, Inc.Align Technology Ltd. · ALIGN TECHNOLOGY LTD. · +1212008–2025Pure Global AI
AustraliaTGAManufacturerAlign Technology IncAlign Technology Ltd162016–2026Pure Global AI
BrazilANVISAManufacturerALIGN TECHNOLOGY, INCALIGN TECHNOLOGY, LTD.132012–2026Pure Global AI
SerbiaALIMSManufacturerAlign Technology, Inc.Align Technology Ltd.132024–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerALIGN TECHNOLOGY, LTD.ALIGNTECH DE MEXICO S, DE R. L. DE C. V. · Align Technology Ltd. · +110—Pure Global AI
Hong KongMDDManufacturerAlign Technology, Inc.Align Technology Inc. · Align Technology Ltd. · +282025–2026Pure Global AI
South KoreaMFDSManufacturerAlign Technology Ltd.Align Technology Inc. · Align Technology Limited · +182002–2026Pure Global AI
PeruDIGEMIDManufacturerALIGN TECHNOLOGY LTD.ALIGN TECHNOLOGY, INC · ALIGN TECHNOLOGY, INC.72019–2025Pure Global AI
ChinaNMPARegistration holder爱齐科技有限公司Align Technology Ltd.爱齐科技股份有限公司Align Technology, Inc · 爱齐科技股份有限公司Align Technology,Inc.3—Pure Global AI
ColombiaINVIMAManufacturerALIGN TECHNOLOGY, INCALIGNTECH DE MEXICO, S DE R.L. DE C.V2—Pure Global AI
Saudi ArabiaSFDAManufacturerALIGN TECHNOLOGY INC.Align Technology Inc.2—Pure Global AI
JapanPMDARegistration holderＡｌｉｇｎ　Ｔｅｃｈｎｏｌｏｇｙ，Ｉｎｃ．12008–2008Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Align Technology, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Sequential AlignerNXC · Class 2Clear alignersMaker
iGoiGo PlusInvisalign ARTInvisalign AssistInvisalign Express 10Invisalign Express 5Invisalign First - ComprehensiveInvisalign First-ComprehensiveInvisalign First-ModerateInvisalign Full
28 more
Invisalign GoInvisalign Go ExpressInvisalign Go PlusInvisalign i7Invisalign LiteInvisalign Palatal ExpanderInvisalign Palatal Expander with Engagement FeaturesInvisalign Palatal HolderInvisalign Palatal Holder with Engagement FeaturesInvisalign Pre-Formed Attachment SystemInvisalign SwiftInvisalign System - ComprehensiveInvisalign System - Comprehensive Phase 2Invisalign System - ExpressInvisalign System - LiteInvisalign System - ModerateInvisalign System - Teen PackageInvisalign System with Integrated ButtonInvisalign System with Mandibular Advancement – Enhanced Precision WingsInvisalign System with Mandibular Advancement – Precision WingsInvisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB)Invisalign System-Comprehensive Phase 2Invisalign TeenInvisalign Touch-UpInvisible Aligner Systemlnvisalign Specifix Attachment Systemlnvisalign Specifix Attachment System (include Engagement Features)3D Treatment Planning Software - ClinCheck Pro 6
2006
Orthodontic SoftwarePNN · Class 2Dental design & orthodontic softwareMaker
iGoiGo PlusInvisalign ARTInvisalign AssistInvisalign Express 10Invisalign Express 5Invisalign First - ComprehensiveInvisalign FullInvisalign GoInvisalign Go Express
17 more
Invisalign Go PlusInvisalign i7Invisalign LiteInvisalign Palatal ExpanderInvisalign Palatal Expander with Engagement FeaturesInvisalign Palatal HolderInvisalign Palatal Holder with Engagement FeaturesInvisalign System - ComprehensiveInvisalign System - Comprehensive Phase 2Invisalign System - ExpressInvisalign System - LiteInvisalign System - ModerateInvisalign System - Teen PackageInvisalign System with Integrated ButtonInvisalign TeenInvisalign Touch-Up3D Treatment Planning Software - ClinCheck Pro 6
2023
Light Transmission Caries DetectorNTK · Class 2Caries detection devicesMaker
iTero Element 5DiTero Element 5D Laptop ConfigurationiTero Element 5D Laptop Configuration, Certified Pre-ownediTero Element 5D PlusiTero Element 5D Plus MobileiTero Element 5D, Full barrier sleeveiTero Lumina ProiTero Lumina Pro MobileiTero Lumina Pro Wand Barrier Sleeves
2020
Orthodontic Space Preformed MaintainerDYT · Class 1Retainers, expanders & headgearMaker
Invisalign Retainerlnvisalign Specifix Attachment Systemlnvisalign Specifix Attachment System (include Engagement Features)Vivera 3D retainerVivera Retainer
2007
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersMaker
GumlinesiOC ScanneriTero ElementiTero Element 2iTero Element 2 PlusiTero Element 2 Plus MobileiTero Element 5D Plus LiteiTero Element FlexiTero Element Flex, Certified Pre-ownediTero Element Scanner Sleeve
8 more
iTero Element SleeveiTero Element, Certified Pre-ownediTero HD2.9 ScanneriTero HDU ScanneriTero LuminaiTero Lumina - PC cfgiTero Lumina MobileiTero Lumina Scanner Sleeve
2011
Indirect Bonding TrayQJJ · Class 1—Maker
Attachment Template
2026
Intraoral CameraQJK · Class 2Intraoral camerasMaker
iTero Lumina ProiTero Lumina Pro MobileiTero Lumina Pro Wand Barrier Sleeves
2024
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesMaker
Cleaning Crystals, Packette
2007
Preformed Impression TrayEHY · Class 1Impression traysMaker
Invisalign Impression Tray Large LowerInvisalign Impression Tray Large UpperInvisalign Impression Tray Medium LowerInvisalign Impression Tray Medium UpperInvisalign Impression Tray Small LowerInvisalign Impression Tray Small UpperInvisalign Impression Tray X-Large LowerInvisalign Impression Tray X-Large Upper
2007
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker
Invisalign Lens
2022
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
Invisalign Cheek Retractor, Medium
2020
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker
Invisalign Detail PliersInvisalign Eraser PliersInvisalign Pliers Set (Detail/Eraser)
2007
Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1—Maker
Invisalign UV Sanitizing Case
2023
ArticulatorsEJP · Class 1Articulators & facebowsMaker
Cadent ArticulatorCadent Articulator KitiTero Articulator Kit
2011

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Align Technology, Inc. as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
25 Sep 2026K262196Invisalign SystemPNN Orthodontic Software
2 Jul 2026K261847iTero Lumina™ ProNTK Light Transmission Caries Detector
23 Oct 2025K252931Invisalign® Palatal Expander SystemNXC Sequential Aligner
9 Oct 2025K252870Invisalign Specifix Attachment SystemNXC Sequential Aligner
29 Aug 2025K252380Invisalign SystemNXC Sequential Aligner
16 Aug 2024K240573iTero Lumina™ ProNTK Light Transmission Caries Detector
18 Jun 2024K241412Invisalign SystemNXC Sequential Aligner
15 Dec 2023K232887Invisalign Palatal Expander SystemNXC Sequential Aligner
26 Sep 2023K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC Sequential Aligner
22 Dec 2022K222894Invisalign System, Pre-Formed Attachment SystemNXC Sequential Aligner
7 Apr 2022K220287Invisalign SystemNXC Sequential Aligner
20 Mar 2020K193659iTero Element 5DNTK Light Transmission Caries Detector
26 Oct 2018K181739Invisalign System with Mandibular Advancement FeatureNXC Sequential Aligner
18 Nov 2015K143630Invisalign SystemNXC Sequential Aligner
17 Dec 2008K081960INVISALIGN SYSTEMNXC Sequential Aligner
8 Sep 1998K981095ALIGN SYSTEMNXC Sequential Aligner

Registered establishments

EstablishmentLocationWhat it does
Align Technology AFAB Poland Sp. z o.o.FDA reg. 3025237243Wroclaw Dolnoslaskie, PolandManufacturer
Align Technology de Costa Rica S.R.LFDA reg. 3005695824Belen Heredia, Costa RicaComplaint file establishment
Align Technology, Inc.FDA reg. 2953749San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer
Align Technology, Ltd.FDA reg. 3009646999Petach Tikva Central, IsraelManufacturer
Aligntech de Mexico S, de R. L. de C. V.FDA reg. 3007527669Cd. Juarez Chihuahua, MexicoManufacturer, Repacker / relabeler
Aligntech de Mexico S, de R. L. de C. V.FDA reg. 3012138716Cd. Juarez Chihuahua, MexicoManufacturer, Repacker / relabeler

Other names on FDA records

Aligntech de Mexico S, de R. L. de C. V. · Align Technology AFAB Poland Sp. z o.o. · Align Technology de Costa Rica S.R.L

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9035576). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.