BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Align Technology, Ltd.

    Reg #: 3009646999 · FEI: 3009646999 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    Align Technology, Ltd.
    Registration Number
    3009646999
    FEI Number
    3009646999
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Yitzhak Rabin Rd.
    City
    Petach Tikva Central
    Country
    IL

    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
    Intraoral Camera QJK
    Caries Detector, Laser Light, Transmission NTK
    Articulators EJP
    Abutment, Implant, Dental, Endosseous NHA
    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

    iTero Lumina Pro iTero Lumina Pro Mobile iTero Lumina Pro Wand Barrier Sleeves 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 Cadent Articulator Kit iTero Articulator Kit Cadent Articulator iTero Software 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 OrthoCAD iQ

    Establishment Types

    Manufacture Medical Device