BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Invisalign System - Lite

    Reg #: 2953749 · FEI: 3002519584 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    Establishment Types
    3
    Classifications
    1

    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
    K220287

    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

    Proprietary Names

    Invisalign System - Lite Invisalign Swift Invisalign Express 10 Invisalign System - Comprehensive Invisalign I7 Invisalign System Orthodontic Appliance Invisalign Express 5 Invisalign Full Invisalign Touch-Up Attachment Template Invisalign System - Express Invisalign First-Comprehensive Invisalign Go Invisalign Lite Invisalign System Invisalign Teen Invisalign System-Comprehensive Phase 2 Invisalign System with Mandibular Advancement – Enhanced Precision Wings Invisalign Go Plus Invisalign System - Teen Package Invisalign Assist Invisalign System - Moderate Invisalign First-Moderate 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System with Mandibular Advancement – Precision Wings

    Establishment Types

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