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Direction Indicator Nobel Biocare N1™
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300918
Identity
- Trade Name
- Direction Indicator Nobel Biocare N1™ EUDAMEDNobel Biocare N1™ FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Direction indicators EUDAMEDDirection Indicator Nobel Biocare N1™ FDA UDI
- Model / Reference
- 300918 EUDAMEDFDA UDI
- Description
- Direction Indicator Nobel Biocare N1™ FDA UDI
Identifiers
- Catalog Number
- 300918 FDA UDI
- Primary DI / UDI-DI
- 07332747176827 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000016377 EUDAMED
- Direct Marketing DI
- 07332747162318 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
- GMDN Term
- Dental implantation depth/angle gauge, 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
Direction Indicator 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 | 733274700000016377 | 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 cfb98ad6-54d4-460f-bcbb-76606859e9ed 61 fields · synced Jul 13, 2026
- FDA UDI af5caf66-b73a-4e87-aba1-b1caf41eb6d3 36 fields · synced May 30, 2026