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On1 Base Xeal™ Conical Connection NP 1.75mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 300191
Identity
- Trade Name
- On1 Base Xeal™ Conical Connection NP 1.75mm EUDAMEDOn1™ FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi-unit prosthetic abutments EUDAMEDOn1 Base Xeal™ Conical Connection NP 1.75mm FDA UDI
- Model / Reference
- 300191 EUDAMEDFDA UDI
- Description
- On1 Base Xeal™ Conical Connection NP 1.75mm FDA UDI
Identifiers
- Catalog Number
- 300191 FDA UDI
- Primary DI / UDI-DI
- 07332747188349 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
- Outer Diameter — 4.775 Millimeter FDA UDIHeight — 1.750 Millimeter FDA UDI
On1 Base Xeal™ Conical Connection NP 1.75mm by Nobel Biocare AB — Class IIb — 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 | 73327470000001687H | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 7ef02ad9-5bcc-494a-a75e-0b4713a9413d 61 fields · synced Jun 19, 2026
- FDA UDI c698caba-dfb4-4b2d-b764-d638d21c6dca 37 fields · synced May 30, 2026