Identity
- Trade Name
- Osteotome FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Instrumentation EUDAMED3.5mm Osteotome FDA UDI
- Model / Reference
- 260-901-535 EUDAMEDFDA UDI
- Description
- 3.5mm Osteotome FDA UDI
Identifiers
- Catalog Number
- 260-901-535 FDA UDI
- Primary DI / UDI-DI
- 00813110026019 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002BRI5Y EUDAMED
- FDA Product Code
- EMM FDA UDI
- EMDN Code
- L150101 ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instrumentation by Bicon, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081311002BRI5Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (2)
- EUDAMED 3392e205-fbf7-4a56-baf9-3d17d0c75c65 61 fields · synced Jul 19, 2026
- FDA UDI 5c7db214-4651-4638-a764-ff3a2ac7580f 35 fields · synced May 30, 2026