BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Align Technology, Inc.

    Reg #: 2953749 · FEI: 3002519584 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    87
    Establishment Types
    3
    Classifications
    17

    Registration Details

    Registration Name
    Align Technology, Inc.
    Registration Number
    2953749
    FEI Number
    3002519584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2820 Orchard Parkway
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232233

    Owner / Operator

    Firm Name
    Align Technology, Inc.
    Operator Number
    9035576
    Address
    410 North Scottsdale Road, Suite 1300
    City
    Tempe
    State
    AZ
    Postal Code
    85281
    Country
    US

    Products

    Device Name Product Code
    Aligner, Sequential NXC
    Orthodontic Software PNN
    Plier, Orthodontic JEX
    Caries Detector, Laser Light, Transmission NTK
    Cleaner, Ultrasonic, Medical Instrument FLG
    Accessories, Retractor, Dental EIF
    Maintainer, Space Preformed, Orthodontic DYT
    Cleanser, Denture, Over The Counter EFT
    Retractor, All Types EIG
    Tray, Impression, Preformed EHY
    Intraoral Camera QJK
    Indirect Bonding Tray QJJ
    Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile NOB
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Bracket, Plastic, Orthodontic DYW
    Bracket, Metal, Orthodontic EJF
    Bracket, Ceramic, Orthodontic NJM

    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 System with Mandibular Advancement – Precision Wings Invisalign System - Teen Package Invisalign System with Mandibular Advancement – Enhanced Precision Wings 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 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 Swift Invisalign First-Moderate Invisalign I7 Invisalign System-Comprehensive Phase 2 Invisalign First-Comprehensive Invisalign System Orthodontic Appliance 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 Realine Invisible Aligner System Invisalign Deluxe Smile Signature Smile Invisalign Signature Plus Smile OrthoCAD iQ

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device