Latch Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
by Bicon, LLC
Identity
- Trade Name
- Latch Reamer FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Latch Instrument EUDAMEDExtended Latch Reamer Kit FDA UDI
- Model / Reference
- 260-101-121 EUDAMEDFDA UDI
- Description
- Extended Latch Reamer Kit FDA UDI
Identifiers
- Catalog Number
- 260-101-121 FDA UDI
- Primary DI / UDI-DI
- 00813110024145 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002LIJ9 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L1508 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
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, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 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 (2)
- EUDAMED c15dee8f-e68e-410b-ba66-1a56d4d9ac76 61 fields · synced Jun 18, 2026
- FDA UDI 71e5145e-053a-4767-94b3-97dce806f188 35 fields · synced May 30, 2026