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Furcation Diamond File
EUDAMEDFDA UDIClass I (EU MDR)
Ref 261-262DXSIModel Dental hand instrument, furcation file for cleaning and forming root surfaces
Identity
- Trade Name
- Furcation Diamond File EUDAMEDLMDental FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDFurcation Diamond File, Periodontics FDA UDI
- Model / Reference
- 261-262DXSI EUDAMEDFDA UDIDental hand instrument, furcation file for cleaning and forming root surfaces EUDAMED
- Description
- Furcation Diamond File, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311211039 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311211039 EUDAMED
- Direct Marketing DI
- 06438311211039 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
- GMDN Term
- Periodontal curette FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland 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
No
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
Furcation Diamond File by LM-Instruments Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311PERIO1r06S | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311PERIO1r06S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (3)
- EUDAMED 8bf2106c-7ca0-4430-ba86-b50f31da26cf 61 fields · synced Jul 10, 2026
- EUDAMED 2346d961-c813-460a-b165-a4b5ff09c825 61 fields · synced May 18, 2026
- FDA UDI fb028560-8945-4dca-8048-545a225a6865 33 fields · synced May 30, 2026