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Trinia
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 260-612-225Ref 260-612-125Ref 260-615-115
by Bicon, LLC
Identity
- Trade Name
- TRINIA EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CAD/CAM Material EUDAMEDTRINIA EUDAMEDTRINIA 98 x 25mm (P) FDA UDITRINIA 98 x 25mm (I) FDA UDITRINIA 89 x 71 x 15mm (I) FDA UDI
- Model / Reference
- 260-612-225 EUDAMEDFDA UDI260-612-125 EUDAMEDFDA UDI260-615-115 EUDAMEDFDA UDI
- Description
- TRINIA 98 x 25mm (P) FDA UDITRINIA 98 x 25mm (I) FDA UDITRINIA 89 x 71 x 15mm (I) FDA UDI
Identifiers
- Catalog Number
- 260-612-225 FDA UDI260-612-125 FDA UDI260-615-115 FDA UDI
- Primary DI / UDI-DI
- 00813110020345 EUDAMEDFDA UDI00813110020147 EUDAMEDFDA UDI00813110020444 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110020345 EUDAMEDB-00813110020147 EUDAMED081311002TRI8S EUDAMED
- FDA Product Code
- EBF FDA UDIEBI FDA UDIEBG FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMEDQ01020603 SKELETAL DENTAL PROSTHESES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3760 FDA UDI872.3770 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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00813110020345 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813110020345 | 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 (8)
- EUDAMED 6d500384-ec06-4399-a985-49678713ae18 61 fields · synced Aug 2, 2026
- EUDAMED e494ef3d-b6c9-4c46-9e58-d702b1274eff 61 fields · synced May 18, 2026
- FDA UDI 1f1b3062-a6d8-44cd-a697-274bb04836fa 36 fields · synced May 29, 2026
- FDA UDI 8d553b58-be97-40dc-abe0-234b374f1e87 36 fields · synced May 30, 2026
- FDA UDI 74b37eef-ac86-4fc8-b21d-61befc90b44d 36 fields · synced May 30, 2026
- EUDAMED 13e45681-b13f-42a8-9bfd-c80807845e43 61 fields · synced Jul 18, 2026
- EUDAMED 52dce6c6-718c-4a68-a64c-d3381eaab671 61 fields · synced Jul 28, 2026
- EUDAMED 5f5dca0d-0765-400d-a840-f6d2b09c4a26 61 fields · synced Aug 2, 2026