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Trinia
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 260-613-115
by Bicon, LLC
Identity
- Trade Name
- TRINIA EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CAD/CAM Material EUDAMEDTRINIA 55 x 19 x 15mm (I) FDA UDI
- Model / Reference
- 260-613-115 EUDAMEDFDA UDI
- Description
- TRINIA 55 x 19 x 15mm (I) FDA UDI
Identifiers
- Catalog Number
- 260-613-115 FDA UDI
- Primary DI / UDI-DI
- 00813110020406 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110020406 EUDAMED
- 510(k) Number
- K133608 FDA UDI
- FDA Product Code
- EBI FDA UDIEBG FDA UDIEBF FDA UDI
- EMDN Code
- Q010699 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
- 872.3760 FDA UDI872.3770 FDA UDI872.3690 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133608 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813110020406 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED 4b2d5ec8-4663-4317-aad3-84c1a1b48eef 61 fields · synced Jul 21, 2026
- FDA UDI 92ab7b28-a0d8-485d-b54e-aff7cf2a8068 36 fields · synced May 30, 2026
- FDA 510(k) K133608 1 fields · synced May 18, 2026