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Multi-unit Abutment Plus Conical Connection NP 2.5mm
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 38881
Identity
- Trade Name
- Multi-unit Abutment Plus Conical Connection NP 2.5mm EUDAMEDMulti-unit Abutment Plus FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi-unit prosthetic abutments EUDAMEDMulti-unit Abutment Plus Conical Connection NP 2.5mm FDA UDI
- Model / Reference
- 38881 EUDAMEDFDA UDI
- Description
- Multi-unit Abutment Plus Conical Connection NP 2.5mm FDA UDI
Identifiers
- Catalog Number
- 38881 FDA UDI
- Primary DI / UDI-DI
- 07332747191981 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001687H EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 2.500 Millimeter FDA UDIOuter Diameter — 4.800 Millimeter FDA UDI
Multi-unit Abutment Plus Conical Connection NP 2.5mm by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K161416 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 73327470000001687H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (3)
- EUDAMED aca11dbb-07a9-400d-b5da-dee34ff134a3 61 fields · synced Jul 28, 2026
- FDA UDI bd166ae4-0675-49b5-9d62-d2246e6b5cac 37 fields · synced May 30, 2026
- FDA 510(k) K161416 1 fields · synced May 18, 2026