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iTero Element Plus Wheel Stand, kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 211563Model Itero Wheel Stand
Identity
- Trade Name
- iTero Element Plus Wheel Stand, kit EUDAMEDiTero Element Plus wheel stand, service FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Itero Wheel Stand EUDAMEDWS service FDA UDI
- Model / Reference
- Itero Wheel Stand EUDAMED211563 EUDAMEDFDA UDI
- Description
- WS service FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020981 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081606302WS7C EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER 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 Plus Wheel Stand, kit 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 | 0081606302WS7C | 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 2bf20935-ef90-4f9e-bb90-a0b9dde3af86 61 fields · synced Jul 9, 2026
- FDA UDI dc50d1d9-5ef7-4ac8-9e72-27feb6e87f25 33 fields · synced May 30, 2026