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Root Canal Excavator 1.0mm DTSU
EUDAMEDClass I (EU MDR)
Ref 612-622ESTUModel Dental hand instrument, excavator for preparation of root canal
Identity
- Trade Name
- Root Canal Excavator 1.0mm DTSU EUDAMEDRoot Canal Excavator 1.0mm DTS U EUDAMED
- Device Name
- Endodontic hand instruments Ir EUDAMED
- Model / Reference
- 612-622ESTU EUDAMEDDental hand instrument, excavator for preparation of root canal EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311041629 EUDAMED
- Basic UDI-DI
- 6438311ENDO1r0SD EUDAMEDB-06438311041629 EUDAMED
- Direct Marketing DI
- 06438311041629 EUDAMED
- EMDN Code
- L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Root Canal Excavator 1.0mm DTSU by LM-Instruments Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438311ENDO1r0SD | Class I | Active |
| EUDAMED | European Union | CE/MDD | 6438311ENDO1r0SD | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED a6902715-ea09-4b41-9db3-a74aa243c35a 61 fields · synced Jun 18, 2026
- EUDAMED d55730a5-ba0b-4ecd-8f11-06dab527c680 61 fields · synced May 17, 2026