Identity
- Trade Name
- Temporary EUDAMEDTemporary Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMED5.0 x 4.5mm Scannable Temporary Abutment - 2.5mm Tall Post FDA UDI
- Model / Reference
- 260-253-795 EUDAMEDFDA UDI
- Description
- 5.0 x 4.5mm Scannable Temporary Abutment - 2.5mm Tall Post FDA UDI
Identifiers
- Catalog Number
- 260-253-795 FDA UDI
- Primary DI / UDI-DI
- 00813110029430 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002TAbut5L 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
Category: Dental implant suprastructure, permanent, preformed
Temporary by Bicon, Llc — Class IIb — 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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- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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 | 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 (2)
- EUDAMED 2b9adf26-b5b6-4901-8663-ca6134ef47e9 61 fields · synced Jul 18, 2026
- FDA UDI f5fe33c4-0d96-4919-a65f-6fd5c06bb324 36 fields · synced May 29, 2026