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Fixed-Detachable
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 260-300-004
by Bicon, LLC
Identity
- Trade Name
- Fixed-Detachable EUDAMEDFixed-Detachable Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMED4.0 x 5.0mm 0° Fixed-Detachable Abutment - 3.0mm Post FDA UDI
- Model / Reference
- 260-300-004 EUDAMEDFDA UDI
- Description
- 4.0 x 5.0mm 0° Fixed-Detachable Abutment - 3.0mm Post FDA UDI
Identifiers
- Catalog Number
- 260-300-004 FDA UDI
- Primary DI / UDI-DI
- 00813110022189 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002TAbut5L EUDAMEDB-00813110022189 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
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
No
FDA UDI
Fixed-Detachable by Bicon, Llc — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
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 17d877ec-590b-46f7-b062-f58867d7e21e 61 fields · synced Jul 15, 2026
- EUDAMED aedca580-32f0-48d8-92cc-fcb12e7ada13 61 fields · synced May 19, 2026
- FDA UDI 9df611ad-634d-421d-8ea0-81f0d6920be9 36 fields · synced May 30, 2026