Identity
- Trade Name
- Integra-Ti EUDAMEDFDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Integra-Ti Implant EUDAMED4.5 x 8.0mm Integra-Ti Implant - 3.0mm Well FDA UDI
- Model / Reference
- 260-145-308 EUDAMEDFDA UDI
- Description
- 4.5 x 8.0mm Integra-Ti Implant - 3.0mm Well FDA UDI
Identifiers
- Catalog Number
- 260-145-308 FDA UDI
- Primary DI / UDI-DI
- 00813110020949 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002ITi8X EUDAMEDB-00813110020949 EUDAMED
- 510(k) Number
- K994037 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Basket endosteal dental implant, two-piece 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
Integra-Ti by Bicon, Llc — Class IIb — 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 | 081311002ITi8X | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081311002ITi8X | 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 (3)
- EUDAMED 740565d3-cf6d-46c4-9192-1fa157f660e3 61 fields · synced Jul 24, 2026
- EUDAMED a4a888e6-8a62-4d9d-a164-455c876bdf2b 61 fields · synced May 19, 2026
- FDA UDI c6831c21-d2eb-4d85-94cf-f024ddea1c32 36 fields · synced May 30, 2026