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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
Website: www.aligntech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jacco de Wit
EUDAMED SRN: US-MF-000000744
FDA FEI Number: 3002519584
DUNS Number: —

Catalogue (119)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
iTero Lumina Pro Upgrade	221946	FDA UDI	Class II	Active
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB)	221572	FDA UDI	Class II	Active
iTero 5D Scanning Unit	211871	FDA UDI	Class II	Active
iTero Lumina Pro Mobile Upgrade	221948	FDA UDI	Class II	Active
Invisalign System with Mandibular advancement - enhanced precision wings	222715	FDA UDI	Class II	Active
Invisalign Express 10	8512	FDA UDI	Class II	Active
Vivera Realine	8567	FDA UDI	Class I	Active
Vivera	8579	FDA UDI	Class I	Active
iTero Lumina Pro Wand Barrier Sleeves	221922	FDA UDI	Class II	Active
The Signature Smile	9016	FDA UDI	Class II	Active
iTero Lumina Pro	221951	FDA UDI	Class II	Active
Invisalign IPR Sub-Assembly	20191	FDA UDI	Class I	Active
Packed 5D Plus US Scanning Unit, RMA	212261	FDA UDI	Class II	Active
Itero Element	108063	FDA UDI	Class II	Active
Invisalign Signature Smile	9025	FDA UDI	Class II	Unknown
iTero Lumina Pro DOA	221971	FDA UDI	Class II	Active
Invisalign Pre-Formed Attachment System	9030	FDA UDI	Class II	Active
Attachment Template	100012	FDA UDI	Class II	Active
Invisalign Signature Plus Smile	9020	FDA UDI	Class II	Active
Itero Element	108064	FDA UDI	Class II	Active
iTero Lumina Pro Mobile	221952	FDA UDI	Class II	Active
iTero Element 5D Plus US wand upgrade	211378	FDA UDI	Class II	Active
Detail Pliers	100050	FDA UDI	Class I	Active
Vivera™ 3D retainers	5016	FDA UDI	Class I	Active
iTero Articulator Kit	107806	FDA UDI	Class I	Active
iTero Lumina Pro Upgrade	221950	FDA UDI	Class II	Active
DOA Kit, 5D US Plus	212270	FDA UDI	Class II	Active
Invisalign Pre-Formed Attachment System	5000	FDA UDI	Class II	Active
Invisalign Deluxe Smile	9019	FDA UDI	Class II	Active
Invisalign Signature Smile	9021	FDA UDI	Class II	Active
DOA Kit, Element 5D Plus Lite	212202	FDA UDI	Class II	Active
Packed 5D Plus Lite Scanning Unit, RMA	212203	FDA UDI	Class II	Active
Erase Pliers	100049	FDA UDI	Class I	Active
Invisalign Swift	9027	FDA UDI	Class II	Active
Invisalign Express 5	8518	FDA UDI	Class II	Active
iTero Element 5D Plus Ready US Mobile configuration	211899	FDA UDI	Class II	Active
NuMe	9004	FDA UDI	Class II	Active
iTero Element 5D Plus US mobile configuration	211492	FDA UDI	Class II	Active
iTero Element 2 Plus upgrade mobile configuration	211372	FDA UDI	Class II	Active
iTero Element 5D US System	209156	FDA UDI	Class II	Active
iTero Lumina Pro	222047	FDA UDI	Class II	Active
iTero Lumina Interface Box	217622	FDA UDI	Class II	Active
iTero Element 5D Plus Ready US Cart configuration	211898	FDA UDI	Class II	Active
iTero Lumina Pro	222049	FDA UDI	Class II	Active
Cleaning Crystals, Packette	20127	FDA UDI	Class I	Active
iTero Element 5D Plus upgrade cart configuration	211572	FDA UDI	Class II	Active
iTero Element Barrier Sleeves	209174	FDA UDI	Class II	Active
iGO	9018	FDA UDI	Class II	Active
iTero Lumina Pro intraoral scanning unit	221925	FDA UDI	Class II	Active
iTero Element 5D Plus wand upgrade	211377	FDA UDI	Class II	Active

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