Fixed-Detachable
EUDAMEDFDA UDIClass IIb (EU MDR)
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 3.0mm 15° Fixed-Detachable Abutment - 2.0mm Post FDA UDI
- Model / Reference
- 260-100-015 EUDAMEDFDA UDI
- Description
- 4.0 x 3.0mm 15° Fixed-Detachable Abutment - 2.0mm Post FDA UDI
Identifiers
- Catalog Number
- 260-100-015 FDA UDI
- Primary DI / UDI-DI
- 00813110020505 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110020505 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
Fixed-Detachable by Bicon, Llc — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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-00813110020505 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00813110020505 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED 94dbc469-1977-4143-9b0d-4e8f6363075a 61 fields · synced Jul 24, 2026
- EUDAMED 2b8f6dd9-f719-4f40-a074-08cc35bf6f28 61 fields · synced May 18, 2026
- FDA UDI 1efd5c42-0993-4224-90bb-4a74620fc54d 36 fields · synced May 30, 2026