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iTero Lumina Pro Mobile
EUDAMEDClass IIa (EU MDR)
Ref 217612Ref 217611Ref 221959Ref 221908
Identity
- Trade Name
- iTero Lumina Pro Mobile EUDAMEDiTero Lumina Pro EUDAMED
- Device Name
- iTero Lumina™ Pro / iTero Lumina™ Pro Mobile EUDAMED
- Model / Reference
- 217612 EUDAMED217611 EUDAMED221959 EUDAMED221908 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022121 EUDAMED00816063022114 EUDAMED00816063022312 EUDAMED00816063022862 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 by Align Technology Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 (4)
- EUDAMED 6b861ba3-afec-4e89-94dc-2f4a760d8fe2 61 fields · synced Aug 4, 2026
- EUDAMED 3544e9cc-4c86-4692-97df-bcf1841d8900 61 fields · synced May 17, 2026
- EUDAMED fc3ede83-3489-4106-95d4-6632f759ba70 61 fields · synced May 18, 2026
- EUDAMED 85818fe4-9eaa-4011-833e-da1caf1f8c2e 61 fields · synced May 18, 2026