Identity
- Trade Name
- Universal EUDAMEDUniversal Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMEDUniversal Abutment UA5 LP 15° - 2.0mm Post FDA UDI
- Model / Reference
- 260-150-705 EUDAMEDFDA UDI
- Description
- Universal Abutment UA5 LP 15° - 2.0mm Post FDA UDI
Identifiers
- Catalog Number
- 260-150-705 FDA UDI
- Primary DI / UDI-DI
- 00813110021137 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110021137 EUDAMED081311002TAbut5L EUDAMED
- 510(k) Number
- K853788 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
Universal by Bicon, Llc — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00813110021137 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00813110021137 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED a7bfe1a3-53dc-420f-aeed-9f21a5348cbe 61 fields · synced Jul 22, 2026
- EUDAMED 0504a598-3ed1-41e9-9a9f-858230242911 61 fields · synced May 16, 2026
- FDA UDI 5a34b1a2-49ae-4f35-a134-caa62d9d852f 36 fields · synced May 22, 2026