← Back to catalogue
Latch Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 260-945-101
by Bicon, LLC
Identity
- Trade Name
- Latch Instrument EUDAMEDGuided Tissue Punch FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Dental Instrument EUDAMEDLatch Instrument EUDAMED4.5mm Guided Tissue Punch FDA UDI
- Model / Reference
- 260-945-101 EUDAMEDFDA UDI
- Description
- 4.5mm Guided Tissue Punch FDA UDI
Identifiers
- Catalog Number
- 260-945-101 FDA UDI
- Primary DI / UDI-DI
- 00813110026422 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813110026422 EUDAMED081311002LIJ9 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159007 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
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-00813110026422 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813110026422 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED d4a72730-3c12-4b5c-9742-6c32d7ee3fbb 61 fields · synced Jun 18, 2026
- EUDAMED 84d3f940-9e44-4087-bd0c-b4f10eea54a3 61 fields · synced May 18, 2026
- FDA UDI 1a32760b-b83a-453d-818b-b67fa6c57d2a 35 fields · synced May 30, 2026