Identity
- Trade Name
- Integra-Ti EUDAMEDFDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- Integra-Ti Implant EUDAMED3.5 x 8.0mm Integra-Ti Implant - 2.0mm Well FDA UDI
- Model / Reference
- 260-135-008 EUDAMEDFDA UDI
- Description
- 3.5 x 8.0mm Integra-Ti Implant - 2.0mm Well FDA UDI
Identifiers
- Catalog Number
- 260-135-008 FDA UDI
- Primary DI / UDI-DI
- 00813110020659 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110020659 EUDAMED081311002ITi8X EUDAMED
- 510(k) Number
- K853788 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 — 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-00813110020659 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00813110020659 | 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 b43ad2a4-c4b0-452c-9bf2-027dca4bb639 61 fields · synced Jul 29, 2026
- EUDAMED 6f1009d0-dc8a-4355-a47f-0bec7d7de54e 61 fields · synced May 18, 2026
- FDA UDI 2c0a4c9d-aa4b-4522-a6f9-1759a0077887 36 fields · synced May 30, 2026