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Round excavator 1.5mm Orbis
EUDAMEDClass I (EU MDR)
Ref 63-64PDOLMModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- Round excavator 1.5mm Orbis EUDAMED
- Device Name
- Restorative hand instrument Ir EUDAMED
- Model / Reference
- 63-64PDOLM EUDAMEDDental hand instrument, excavator for the removal of softened carious dentin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706603 EUDAMED
- Basic UDI-DI
- 6438311RESTO1r0C6 EUDAMEDB-06438311706603 EUDAMED
- Direct Marketing DI
- 06438311706603 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
Round excavator 1.5mm Orbis by LM-Instruments Oy — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311RESTO1r0C6 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311RESTO1r0C6 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED b41f6f14-925c-4fc0-aeca-81ec3831e0f3 61 fields · synced Jul 23, 2026
- EUDAMED ad304543-e732-4d9d-9096-5fb8e70bbe5b 61 fields · synced May 19, 2026