Fixed-Detachable
EUDAMEDFDA UDIClass IIb (EU MDR)
by Bicon, LLC
Identity
- Trade Name
- Fixed-Detachable EUDAMEDFixed-Detachable Universal Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMED4mm FDUA SP 15° - 3.0mm Standard Post FDA UDI
- Model / Reference
- 260-302-315 EUDAMEDFDA UDI
- Description
- 4mm FDUA SP 15° - 3.0mm Standard Post FDA UDI
Identifiers
- Catalog Number
- 260-302-315 FDA UDI
- Primary DI / UDI-DI
- 00813110028440 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002TAbut5L EUDAMEDB-00813110028440 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
Fixed-Detachable by Bicon, Llc — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081311002TAbut5L | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081311002TAbut5L | 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 7b65a4c6-73db-4ee4-a8c7-87e274b7acf5 61 fields · synced Aug 1, 2026
- EUDAMED 846fb2cc-41dc-4dfd-81b7-02b8baa85961 61 fields · synced May 19, 2026
- FDA UDI 6de5234c-9c65-473a-afc5-a4d42493b8bc 36 fields · synced May 25, 2026