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Nobel Biocare Multi-unit PoLo Link 20mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 301949
Identity
- Trade Name
- Nobel Biocare Multi-unit PoLo Link 20mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, reusable FDA UDI
- Device Name
- Transfer to model tools Ir EUDAMEDNobel Biocare Multi-unit PoLo Link 20mm FDA UDI
- Model / Reference
- 301949 EUDAMEDFDA UDI
- Description
- Nobel Biocare Multi-unit PoLo Link 20mm FDA UDI
Identifiers
- Catalog Number
- 301949 FDA UDI
- Primary DI / UDI-DI
- 07332747215090 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000013674 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 20.000 Millimeter FDA UDI
Nobel Biocare Multi-unit PoLo Link 20mm by Nobel Biocare AB — 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 | 733274700000013674 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 97be5e56-7842-4cd9-96c6-1f585f04f345 61 fields · synced Sep 17, 2026
- FDA UDI 3b2d8362-a532-4bee-b27c-1c41679e1a01 37 fields · synced May 30, 2026