BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Invisalign System - Moderate

    Reg #: 2953749 · FEI: 3002519584 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Align Technology, Inc.
    Registration Number
    2953749
    FEI Number
    3002519584
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2820 Orchard Parkway
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241412

    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

    Proprietary Names

    Invisalign System - Moderate 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign Go Express Invisalign Assist Invisalign Go Plus Invisalign Touch-Up Invisalign System - Teen Package Invisalign System Invisalign Lite Invisalign Express 5 Invisalign System - Comprehensive Phase 2 Invisalign First - Comprehensive Invisalign Teen iGo iGo Plus Invisalign System - Comprehensive Invisalign Access Invisalign System - Express Invisalign Full Invisalign Express 10 Invisalign i7 Invisalign System - Lite Attachment Template Invisalign Go

    Establishment Types

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