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Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref 260-701-380Ref 260-801-075Ref 260-801-070Ref 260-101-540
by Bicon, LLC
Identity
- Trade Name
- Tissue Punch FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Instrumentation EUDAMED4.0mm Tissue Punch FDA UDI
- Model / Reference
- 260-701-380 EUDAMED260-801-075 EUDAMED260-801-070 EUDAMED260-101-540 EUDAMEDFDA UDI
- Description
- 4.0mm Tissue Punch FDA UDI
Identifiers
- Catalog Number
- 260-101-540 FDA UDI
- Primary DI / UDI-DI
- 00813110025586 EUDAMED00813110029799 EUDAMED00813110029782 EUDAMED00813110024466 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002BRI5Y EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMEDQ010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMEDL159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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 (5)
- EUDAMED 6f51f98a-7f8b-462b-9ee6-47bec21c08ff 61 fields · synced Jul 31, 2026
- EUDAMED 39f107bf-b55f-4e86-9e64-5d9b9e705108 61 fields · synced May 16, 2026
- EUDAMED 6fd001c9-ecf7-4720-98e6-a66fd13b2f38 61 fields · synced May 17, 2026
- EUDAMED 0f5476c1-2800-4fe2-84e5-8cb1194461db 61 fields · synced May 17, 2026
- FDA UDI 5659cc03-ea6f-4163-8b3a-0c060cd59990 35 fields · synced May 26, 2026