Identity
- Trade Name
- iTero Lumina PC cfg EUDAMEDiTero Lumina – PC cfg FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Lumina – PC cfg EUDAMEDPaired Unit, Performance PC Config, Lumina FDA UDI
- Model / Reference
- 223111 EUDAMEDFDA UDI
- Description
- Paired Unit, Performance PC Config, Lumina FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063023241 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302LMN22SYSEL EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Medical Purpose
- iTero Lumina PC cfg intraoral scanning unit: The iTero Lumina PC cfg intraoral scanning unit is intended to capture 3D and 2D color images of the patient’s oral cavity. The intraoral scanner is intended to record the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. iTero Lumina software: The data processing, displayed and stored by the iTero Lumina Software may be used by dental healthcare professionals for assessing intraoral topographical images of hard and soft tissue and visual assessments. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Lumina PC cfg by Align Technology Ltd. — Class I — 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 | 081606302LMN22SYSEL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-PR-000047276
Sources (2)
- EUDAMED f3aed019-3a8c-4230-af34-d91e8d4136f5 61 fields · synced Jun 18, 2026
- FDA UDI efd3311f-70d7-44f8-85df-de3f63aa6a6c 33 fields · synced May 29, 2026