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Manual Torque Wrench Surgical Nobel Biocare N1™
EUDAMEDFDA UDIClass I (EU MDR)
Ref 301083
Identity
- Trade Name
- Manual Torque Wrench Surgical Nobel Biocare N1™ EUDAMEDNobel Biocare N1™ FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Torque wrenches EUDAMEDManual Torque Wrench Surgical Nobel Biocare N1™ FDA UDI
- Model / Reference
- 301083 EUDAMEDFDA UDI
- Description
- Manual Torque Wrench Surgical Nobel Biocare N1™ FDA UDI
Identifiers
- Catalog Number
- 301083 FDA UDI
- Primary DI / UDI-DI
- 07332747163544 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001887P EUDAMED
- Direct Marketing DI
- 07332747163544 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental torque wrench 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
Yes
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
Manual Torque Wrench Surgical Nobel Biocare N1™ 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 | 73327470000001887P | 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 5b6793ee-8afb-44f7-82b6-303a34a26ef7 61 fields · synced Jul 25, 2026
- FDA UDI b067cddc-796a-47c8-8dbf-84f6834a4bb2 36 fields · synced May 29, 2026