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Position Locator Single Abutment Nobel Biocare On1
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300437
Identity
- Trade Name
- Position Locator Single Abutment Nobel Biocare On1 EUDAMEDOn1™ FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Lab position locators EUDAMEDPos Loc Single Abut Nobel Biocare On1 FDA UDI
- Model / Reference
- 300437 EUDAMEDFDA UDI
- Description
- Pos Loc Single Abut Nobel Biocare On1 FDA UDI
Identifiers
- Catalog Number
- 300437 FDA UDI
- Primary DI / UDI-DI
- 07332747176421 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001967N EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Position Locator Single Abutment Nobel Biocare On1 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 | 73327470000001967N | 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 b5bb3ba0-c0ca-476e-8ec0-72d369e4a813 61 fields · synced Jun 18, 2026
- FDA UDI 67be80cf-ca69-48ed-a802-23ce79a146e9 37 fields · synced May 30, 2026