Latch Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
by Bicon, LLC
Identity
- Trade Name
- Latch Instrument EUDAMEDLatch Reamer FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Latch Instrument EUDAMEDDental Instrument EUDAMED3.0mm Extended Latch Reamer FDA UDI
- Model / Reference
- 260-101-330 EUDAMEDFDA UDI
- Description
- 3.0mm Extended Latch Reamer FDA UDI
Identifiers
- Catalog Number
- 260-101-330 FDA UDI
- Primary DI / UDI-DI
- 00813110024305 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002LIJ9 EUDAMEDB-00813110024305 EUDAMED
- Direct Marketing DI
- 00813110024305 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L1508 REAMERS, REUSABLE EUDAMEDL159007 ODONTOSTOMATOLOGY BURS, 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Cannulated surgical drill bit, reusable
Latch Instrument by Bicon, Llc — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081311002LIJ9 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 081311002LIJ9 | 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 46a6e389-15bc-4134-80c9-a754d9336d75 61 fields · synced Jul 21, 2026
- EUDAMED eefdc8ec-76f3-4321-9002-892ce210f85d 61 fields · synced May 16, 2026
- FDA UDI e7c4eae9-f3bb-42f9-a74c-1c598fac5a40 35 fields · synced May 25, 2026