← Back to catalogue
On1 Universal Abutment 1.25 mm NP
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 38708
Identity
- Trade Name
- On1 Universal Abutment 1.25 mm NP EUDAMED
- Device Name
- Multi-unit prosthetic abutments EUDAMED
- Model / Reference
- 38708 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332747212884 EUDAMED
- Basic UDI-DI
- 73327470000001687H EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
On1 Universal Abutment 1.25 mm NP by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181869 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 73327470000001687H | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 4f84c495-d56f-47d3-8967-e1c5416c2307 61 fields · synced Jun 19, 2026
- FDA 510(k) K181869 1 fields · synced May 18, 2026