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iTero Plus Mobile Computing unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 212266Model iTero Plus Series Platform, Accessories for iTero Scanners
Identity
- Trade Name
- iTero Plus Mobile Computing unit EUDAMEDPacked iTero Mobile Computing Unit RMA 5D Plus FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMEDPPC RMAs FDA UDI
- Model / Reference
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMED212266 EUDAMEDFDA UDI
- Description
- PPC RMAs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021063 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081606302PlusMCU5U EUDAMED
- 510(k) Number
- K193659 FDA UDI
- FDA Product Code
- NTK FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1745 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Plus Mobile Computing unit 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 | 0081606302PlusMCU5U | 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 b46474d8-54e2-4ae1-b8c8-88d24b390a20 61 fields · synced Jul 11, 2026
- FDA UDI 2da5f7ce-3802-4cd0-80f1-59b707d4ac94 34 fields · synced May 25, 2026