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iTero Element Scanner Sleeve
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 109236Model iTero Element Scanner Sleeves
Identity
- Trade Name
- iTero Element Scanner Sleeve EUDAMEDiTero Element Scanner Sleeve (25pcs/Box) FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Element Scanner Sleeves EUDAMEDScanner Sleeve FDA UDI
- Model / Reference
- iTero Element Scanner Sleeves EUDAMED109236 EUDAMEDFDA UDI
- Description
- Scanner Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020585 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302SLEEVE6S EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z12119085 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Element Scanner Sleeve 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 | 081606302SLEEVE6S | 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 f6597f69-fc50-4350-b796-7db10550a733 61 fields · synced Jun 17, 2026
- FDA UDI 4093e94d-f1c7-4427-8348-88765d96f110 33 fields · synced May 29, 2026