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E5D Plus Scanning Unit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 211783Model iTero Element 5D Family
Identity
- Trade Name
- E5D Plus Scanning Unit EUDAMEDiTero 5D Scanning Unit FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Element 5D Family EUDAMEDScanning unit FDA UDI
- Model / Reference
- iTero Element 5D Family EUDAMED211783 EUDAMEDFDA UDI
- Description
- Scanning unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020868 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302DISBH EUDAMED
- 510(k) Number
- K193659 FDA UDI
- FDA Product Code
- NTK FDA UDI
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class IIa 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
E5D Plus Scanning Unit by Align Technology Ltd. — Class IIa — 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 | 081606302DISBH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 39dc1e8e-9ca6-44c2-bfb4-2b4242419bd7 61 fields · synced Jul 9, 2026
- FDA UDI 9407884a-0612-49f3-8e5a-2682ce1f97f8 34 fields · synced May 29, 2026