Identity
- Trade Name
- iTero Lumina Pro Mobile Upgrade EUDAMED
- Device Name
- iTero Lumina™ Pro / iTero Lumina™ Pro Mobile EUDAMED
- Model / Reference
- 221940 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022374 EUDAMED
- Basic UDI-DI
- 081606302LMNPRO88 EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- iTero Lumina Pro is dental imaging system intended to record and display the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. The system is also intended to record and display near infrared images of the teeth to aid in detecting interproximal caries above the gingiva and monitoring the progress of such lesions. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Dental implant suprastructure, temporary, preformed, single-use
iTero Lumina Pro Mobile Upgrade by Align Technology Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302LMNPRO88 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-PR-000047276
Sources (1)
- EUDAMED e0c37518-0a6e-41c4-964d-91c8671cb9a8 61 fields · synced Jul 11, 2026