BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

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

    Reg #: 3007527669 · FEI: 3007527669 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    83
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    Aligntech de Mexico S, de R. L. de C. V.
    Registration Number
    3007527669
    FEI Number
    3007527669
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Boulevard Independencia 1951, Parque Industrial Salvacar
    City
    Cd. Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K240573

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

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device