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Latch Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 260-101-335
by Bicon, LLC
Identity
- Trade Name
- Latch Instrument EUDAMEDLatch Reamer FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Dental Instrument EUDAMEDLatch Instrument EUDAMED3.5mm Extended Latch Reamer FDA UDI
- Model / Reference
- 260-101-335 EUDAMEDFDA UDI
- Description
- 3.5mm Extended Latch Reamer FDA UDI
Identifiers
- Catalog Number
- 260-101-335 FDA UDI
- Primary DI / UDI-DI
- 00813110024312 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110024312 EUDAMED081311002LIJ9 EUDAMED
- Direct Marketing DI
- 00813110024312 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMEDL1508 REAMERS, REUSABLE EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
No
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
Latch Instrument by Bicon, Llc — Class IIa — 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-00813110024312 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813110024312 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ec6ff26c-42a5-4baf-8b9b-4609af53d279 61 fields · synced Jun 20, 2026
- EUDAMED 18466077-7351-4f24-ac22-1cf5fc9f74a8 61 fields · synced May 19, 2026
- FDA UDI ea71602b-7e2c-4eac-a25f-29e3e70c2e5d 35 fields · synced May 30, 2026