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Align Technology, Inc.

United States·US-MF-000000744

Last updated September 17, 2026

Information

Country
United States
Address
2820, Orchard Parkway, San Jose, United States
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Jacco de Wit
EUDAMED SRN
US-MF-000000744
FDA FEI Number
3002519584
DUNS Number
—

Catalogue (119)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
iTero Element 5D Plus upgrade mobile configuration 211573
FDA UDI
Class IIActive
iTero Element 5D Plus US cart configuration 211485
FDA UDI
Class IIActive
iGO Plus 9017
FDA UDI
Class IIActive
iTero Element 5D Sleeves 204284
FDA UDI
Class IIActive
Invisalign EZ-Trim Polishing Wheel 100046
FDA UDI
Class IActive
Vivera™ 4D Retainers 9039
FDA UDI
Class IUnknown
iTero Element 5D LC Upgrade, Kit US 209157
FDA UDI
Class IIActive
Invisalign 1011
FDA UDI
Class IActive
Invisalign UV Sanitizing Case 214150
FDA UDI
Class IActive
NuMe 9005
FDA UDI
Class IIUnknown
Invisalign Assist 8534
FDA UDI
Class IIActive
iTero Element 5D upgrade, Kit US 209176
FDA UDI
Class IIActive
Realine 8554
FDA UDI
Class IIActive
iTero Element 5D US Laptop Configuration 209155
FDA UDI
Class IIActive
Invisalign™ Ultrasonic Cleaning Station 218277
FDA UDI
Class IActive
iTero Element 2 Plus upgrade cart configuration 211376
FDA UDI
Class IIActive
Invisalign System with Mandibular advancement - precision wings 222716
FDA UDI
Class IIActive
Invisalign lens (Sm EU Secondary) 223597
EUDAMED
Class IActive
Virtual Care 3.0 SW-0000249
EUDAMED
Class IActive
Invisalign Go 9014
EUDAMEDFDA UDI
Class IIaActive
Invisalign System - Moderate 9001
EUDAMEDFDA UDI
Class IIaActive
Invisalign Cleaning Crystals 3 pcs 202877
EUDAMED
Class IActive
Invisalign Impression Tray, Plastic, Lower, Small 2569
EUDAMEDFDA UDI
Class IActive
Invisalign Specifix Attachment System with Engagement Features: 5035
EUDAMED
Class IIaActive
Invisalign Go Express 9033
EUDAMEDFDA UDI
Class IIaActive
Invisalign Specifix Attachment System K252870
EUDAMEDFDA 510(k)
Class IIActive
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks K232233
FDA 510(k)
Class IIActive
Invisalign System with Mandibular Advancement Feature K181739
FDA 510(k)
Class IIActive
Invisalign System, Pre-Formed Attachment System K222894
FDA 510(k)
Class IIActive
Invisalign Cleaning System for Aligners and Retainers (with Tub) 76008
EUDAMED
Class IActive
Invisalign Go Plus 9012
EUDAMEDFDA UDI
Class IIaActive
Invisalign Pliers Set (Detail/Eraser) 76018
EUDAMEDFDA UDI
Class IActive
Invisalign Impression Tray, Plastic, Lower, X-Large 2566
EUDAMEDFDA UDI
Class IActive
ClinCheck Pro 6 SW-0000159
EUDAMEDFDA UDI
Class IIaActive
Invisalign lens (Std EU Core) 223594
EUDAMED
Class IActive
Invisalign System – Express 9003
EUDAMEDFDA UDI
Class IIaActive
Invisalign lens (Std EU Secondary) 223596
EUDAMED
Class IActive
Invisalign Impression Tray, Plastic, Upper, Medium 2565
EUDAMEDFDA UDI
Class IActive
Invisalign First-Moderate 9006
EUDAMEDFDA UDI
Class IIaActive
Invisalign ART 9050
EUDAMED
Class IIaActive
Invisalign lens (Sm EU Core) 223595
EUDAMED
Class IActive
Invisalign Impression Tray, Plastic, Lower, Large 2567
EUDAMEDFDA UDI
Class IActive
Invisalign Palatal Expander 9031
EUDAMEDFDA UDI
Class IIaActive
Invisalign Detail Pliers 76017
EUDAMED
Class IActive
Invisalign Comprehensive Intervals 9052
EUDAMED
Class IIaActive
Invisalign Impression Tray, Plastic, Upper, Large 2564
EUDAMEDFDA UDI
Class IActive
Invisalign Impression Tray, Plastic, Upper, Small 2562
EUDAMEDFDA UDI
Class IActive
Invisalign Cheek Retractor, Medium 202430
EUDAMEDFDA UDI
Class IActive
Invisalign Teen 8506
EUDAMEDFDA UDI
Class IIaActive
Invisalign First Intervals 9051
EUDAMED
Class IIaActive

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