BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Aligntech de Mexico S, de R. L. de C. V.

    Reg #: 3012138716 · FEI: 3012138716 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    84
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    Aligntech de Mexico S, de R. L. de C. V.
    Registration Number
    3012138716
    FEI Number
    3012138716
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Avenida Intermex # 1357, Parque Industrial Intermex
    City
    Cd. Juarez Chihuahua
    Country
    MX

    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

    US Agent

    Business Name
    Align Technology, Inc.
    Contact Name
    Lifei Liu
    Address
    2820 Orchard Pkwy
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US
    Email
    [email protected]
    Phone
    408 4701000

    Products

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

    Proprietary Names

    Invisalign Lens 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 Impression Tray Align Ltd. Impression Tray 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System with Mandibular Advancement featuring Occlusal Blocks 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 Detail Plier Eraser Plier Vivera Retainer Invisalign Retainer Vivera 3D retainer 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 Invisalign System with Mandibular Advancement – Enhanced Precision Wings Invisalign System with Mandibular Advancement – Precision Wings Invisalign I7 Invisalign System, Pre-Formed Attachment Systems Invisalign Palatal Holder Invisalign Palatal Expander Invisalign System with Integrated Button iTero Lumina Pro iTero Lumina Pro Mobile iTero Lumina Pro Wand Barrier Sleeves Invisalign System - Comprehensive Phase 2 Invisalign First - Comprehensive Invisalign Access iGo Plus Invisalign Go Express iGo Invisalign ART Invisalign Cleaning System Invisalign Cleaning Crystals Invisalign Starter Kit with Cleaning Crystals Invisalign Palatal Holder with Engagement Features Invisalign Palatal Expander System Invisalign Palatal Expander with Engagement Features Invisalign UV Sanitizing Case Attachment Template Invisalign Ultrasonic Cleaning Station Invisalign Cheek Retractor, Medium

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device