BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Align Technology de Costa Rica S.R.L

    Reg #: 3005695824 · FEI: 3005695824 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    17

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Align Technology de Costa Rica S.R.L
    Registration Number
    3005695824
    FEI Number
    3005695824
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    San Antonio Business Park 112, Arbolito Street
    City
    Belen Heredia
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K252931

    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
    Indirect Bonding Tray QJJ
    Cleanser, Denture, Over The Counter EFT
    Aligner, Sequential NXC
    Orthodontic Software PNN
    Bracket, Plastic, Orthodontic DYW
    Bracket, Metal, Orthodontic EJF
    Bracket, Ceramic, Orthodontic NJM
    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
    Maintainer, Space Preformed, Orthodontic DYT
    Accessories, Retractor, Dental EIF
    Cleaner, Ultrasonic, Medical Instrument FLG
    Retractor, All Types EIG
    Plier, Orthodontic JEX
    Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile NOB

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198