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iTero Element 2 Plus
EUDAMEDFDA UDIClass I (EU MDR)
Ref 211483Model iTero Element 2 family
Identity
- Trade Name
- iTero Element 2 Plus EUDAMEDiTero Element 2 Plus, cart configuration FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Element 2 family EUDAMEDScanner, cart configuration FDA UDI
- Model / Reference
- iTero Element 2 family EUDAMED211483 EUDAMEDFDA UDI
- Description
- Scanner, cart configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020684 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302ELEMENT6L 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
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Element 2 Plus 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 | 081606302ELEMENT6L | 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-MF-000000745
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED 0d991eb4-dd3d-45c0-80fa-cc186fb5c94d 61 fields · synced Jul 16, 2026
- FDA UDI 2d2b1ed3-338e-4ecf-b32a-57f6120d2859 33 fields · synced May 30, 2026