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iTero Element 2 Plus upgrade mobile configuration
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- iTero Element 2 Plus upgrade mobile configuration FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Scanner, mobile configuration FDA UDI
- Model / Reference
- 211372 FDA UDI
- Description
- Scanner, mobile configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020769 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental milling system, CAD/CAM, chairside
iTero Element 2 Plus upgrade mobile configuration by Align Technology, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (2)
- FDA UDI b8e1d100-3355-4a25-9e24-15e59186ca50 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026