Identity
- Trade Name
- TRINIA EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- TRINIA EUDAMEDCAD/CAM Material EUDAMEDTRINIA 89 x 71 x 15mm (P) FDA UDI
- Model / Reference
- 260-615-215 EUDAMEDFDA UDI
- Description
- TRINIA 89 x 71 x 15mm (P) FDA UDI
Identifiers
- Catalog Number
- 260-615-215 FDA UDI
- Primary DI / UDI-DI
- 00813110020451 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002TRI8S EUDAMEDB-00813110020451 EUDAMED
- 510(k) Number
- K143524 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01020603 SKELETAL DENTAL PROSTHESES EUDAMEDQ010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trinia by Bicon, Llc — Class IIa — 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 | 081311002TRI8S | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081311002TRI8S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 5529fffb-39cf-4fcc-8e2b-45ffab75bcd1 61 fields · synced Jul 11, 2026
- EUDAMED 999eb2ef-ed7c-48d4-b77b-bcf3a66d6d66 61 fields · synced May 17, 2026
- FDA UDI a777cade-cab0-46b1-b580-a1aec8b3d778 36 fields · synced May 30, 2026