Identity
- Trade Name
- LM Tunella DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Periodontal knife FDA UDI
- Device Name
- Periodontal surgery hand instruments EUDAMEDLM Tunella DTS U, Tunneling knife FDA UDI
- Model / Reference
- 175-177ESTU EUDAMEDFDA UDI
- Description
- LM Tunella DTS U, Tunneling knife FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311707624 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIOSURGERY1r03D EUDAMED
- Direct Marketing DI
- 06438311707624 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Periodontal knife 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
LM Tunella DTS U by LM-Instruments Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438311PERIOSURGERY1r03D | 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 (2)
- EUDAMED 1de6c033-1352-4d2d-9f3e-afbc2612450a 61 fields · synced Jun 17, 2026
- FDA UDI ecf31ae0-cc03-4239-9026-4c4ad599774e 33 fields · synced May 30, 2026