Align Technology, Inc.

FDA Device Registration & Listing · San Jose, CA, US · Registration 2953749

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2953749
FEI Number
3002519584
Entity Name
Align Technology, Inc.
City/State/Country
San Jose, CA, US
Establishment Address
2820 Orchard Parkway, San Jose, CA 95134, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
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
Y
Expiration Date (Year)
2026
510(k) Number
K981095
PMA Number
N/A

All Registered Proprietary Names

3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System with Mandibular Advancement featuring Occlusal Blocks Invisalign Palatal Holder Invisalign Palatal Holder with Engagement Features Invisalign Palatal Expander System Invisalign Palatal Expander with Engagement Features Invisalign Palatal Expander Invisalign Palatal Holder Invisalign Palatal Expander Invisalign System with Mandibular Advancement – Precision Wings Invisalign System - Teen Package Invisalign System with Mandibular Advancement – Enhanced Precision Wings 3D Treatment Planning Software - ClinCheck Pro 6 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System - Comprehensive Phase 2 Invisalign Touch-Up Invisalign i7 Invisalign System - Lite Invisalign Go Invisalign Go Plus Invisalign First - Comprehensive Invisalign Full Invisalign Teen Invisalign Express 5 Invisalign System - Teen Package Invisalign Access Invisalign System - Comprehensive iGo Plus Invisalign Assist Invisalign Express 10 Invisalign Go Express Invisalign Lite iGo Invisalign System - Express Invisalign System - Moderate Invisalign ART Detail Plier Eraser Plier 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 Invisalign Ultrasonic Cleaning Station Invisalign Lens Invisalign System with Integrated Button Vivera Retainer Invisalign Retainer Vivera 3D retainer Invisalign System, Pre-Formed Attachment Systems Invisalign Cleaning System Invisalign Cleaning Crystals Invisalign Starter Kit with Cleaning Crystals lnvisalign Specifix Attachment System (include Engagement Features) lnvisalign Specifix Attachment System Invisalign Cheek Retractor, Medium Impression Tray Align Ltd. Impression Tray iTero Lumina Pro iTero Lumina Pro Mobile iTero Lumina Pro Wand Barrier Sleeves Attachment Template Invisalign UV Sanitizing Case Invisalign System with Mandibular Advancement – Enhanced Precision Wings Invisalign System - Express Invisalign System - Lite Invisalign Go Invisalign Touch-Up Invisalign Lite Invisalign Swift Invisalign Go Plus Invisalign System with Mandibular Advancement – Precision Wings Invisalign Full Invisalign System - Comprehensive Invisalign Teen Invisalign First-Moderate Invisalign I7 Invisalign Express 10 Invisalign System - Moderate Invisalign System - Teen Package Invisalign System-Comprehensive Phase 2 Invisalign Assist Invisalign Express 5 Invisalign First-Comprehensive Invisalign System Orthodontic Appliance 3D Treatment Planning Software - ClinCheck Pro 6 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 Invisalign Assist Invisalign Express 10 Invisalign Teen Realine Invisalign i7 Invisalign Lite Invisalign System Orthodontic Appliance Invisalign Go Invisible Aligner System Invisalign System - Comprehensive Invisalign System - Lite Invisalign First-Moderate Invisalign System - Moderate Invisalign System - Express Invisalign First-Comprehensive Invisalign Deluxe Smile Signature Smile Invisalign System-Comprehensive Phase 2 Invisalign Go Plus Invisalign Signature Plus Smile Invisalign Swift Invisalign Touch-Up Invisalign System - Teen Package Invisalign Full Invisalign Express 5

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NXC Aligner, Sequential Dental Class 2 872.5470 2023-11-28
NXC Aligner, Sequential Dental Class 2 872.5470 2025-11-17
PNN Orthodontic Software Dental Class 2 872.5470 2025-11-17
PNN Orthodontic Software Dental Class 2 872.5470 2023-12-20
NXC Aligner, Sequential Dental Class 2 872.5470 2023-12-20
NXC Aligner, Sequential Dental Class 2 872.5470 2018-11-09
NXC Aligner, Sequential Dental Class 2 872.5470 2024-07-03
PNN Orthodontic Software Dental Class 2 872.5470 2024-07-03
JEX Plier, Orthodontic Dental Class 1 872.4565 2007-04-04
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2020-03-24
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2023-07-21
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2022-09-30
NXC Aligner, Sequential Dental Class 2 872.5470 2025-09-02
PNN Orthodontic Software Dental Class 2 872.5470 2025-09-02
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2007-10-26
NXC Aligner, Sequential Dental Class 2 872.5470 2023-01-19
EFT Cleanser, Denture, Over The Counter Dental Class 1 872.3520 2007-04-04
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2025-11-18
NXC Aligner, Sequential Dental Class 2 872.5470 2025-11-18
EIG Retractor, All Types Dental Class 1 872.4565 2020-04-22
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2007-04-04
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
QJJ Indirect Bonding Tray Dental Class 1 872.5410 2026-01-29
NOB Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile Dental Class 1 872.6855 2023-01-18
NXC Aligner, Sequential Dental Class 2 872.5470 2022-09-21
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2011-12-05
NXC Aligner, Sequential Dental Class 2 872.5470 2006-04-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3025237243 Align Technology AFAB Poland Sp. z o.o. Wroclaw Dolnoslaskie, PL
3009646999 Align Technology, Ltd. Petach Tikva Central, IL
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
K902838 Denture Dynamic'S, Inc. DENTURE DYNAMIC'S DENTURE MAGIC 1990-09-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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3017155477 uLab Systems, Inc Memphis, TN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2953749. Last updated year: 2026. Please use registration number 2953749 when referencing this establishment in official correspondence.
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