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iTero Lumina Pro Software
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 225979Model iTero Lumina Pro Software
Identity
- Trade Name
- iTero Lumina Pro Software EUDAMEDiTero Lumina Pro FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- iTero Lumina Pro Software EUDAMEDFDA UDI
- Model / Reference
- iTero Lumina Pro Software EUDAMED225979 EUDAMEDFDA UDI
- Description
- iTero Lumina Pro Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063023067 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302SWPROAL EUDAMED
- 510(k) Number
- K240573 FDA UDI
- FDA Product Code
- NTK FDA UDIQJK FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1745 FDA UDI872.3661 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
iTero Lumina Pro Software by Align Technology Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302SWPROAL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-MF-000000745
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED c313814f-9aa1-4502-b02a-f8c19ffe28cb 61 fields · synced Jun 17, 2026
- FDA UDI 3295bca2-bd27-47dc-ae1a-0f46951577c4 34 fields · synced May 29, 2026