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Furcator KS DTS U
EUDAMEDFDA UDIClass I (EU MDR)
Ref 259-260ESTUModel Dental hand instrument, excavator for cleaning furcation area
Identity
- Trade Name
- Furcator KS DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDFurcator KS DTS U, Periodontics FDA UDI
- Model / Reference
- 259-260ESTU EUDAMEDFDA UDIDental hand instrument, excavator for cleaning furcation area EUDAMED
- Description
- Furcator KS DTS U, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311021874 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311021874 EUDAMED
- Direct Marketing DI
- 06438311021874 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
- GMDN Term
- Dental excavator, reusable 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
Furcator KS DTS U by LM-Instruments Oy — Class I — 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 | 6438311PERIO1r06S | Class I | Active |
| EUDAMED | European Union | CE/MDD | 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 e09b3deb-2542-442c-8bec-8b03dac76912 61 fields · synced Jul 24, 2026
- EUDAMED 57090731-b2e4-492f-b6f8-5794dad4944a 61 fields · synced May 16, 2026
- FDA UDI 737e4156-6f8c-4af6-9082-c8c4d2cf45ba 33 fields · synced May 30, 2026