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Plastic instrument, anterior
EUDAMEDClass I (EU MDR)
Ref 43-47SIRef 43-47PDOLMRef 43-47PDLM
Identity
- Trade Name
- Plastic instrument, anterior EUDAMEDPlastic Instrument, anterior Orbis EUDAMED
- Device Name
- Restorative dental hand instrument EUDAMED
- Model / Reference
- 43-47SI EUDAMED43-47PDOLM EUDAMED43-47PDLM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311214856 EUDAMED06438311706658 EUDAMED06438311706863 EUDAMED
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311214856 EUDAMED06438311706658 EUDAMED06438311706863 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Dental appliance fabrication material, ceramic
Plastic instrument, anterior by LM-Instruments Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438311RESTO102Y | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (3)
- EUDAMED 95c0e19e-dd45-415f-8185-9ec627d2e1af 61 fields · synced Jul 23, 2026
- EUDAMED f8dff73e-e2e7-4101-9d6d-3f83e7409f46 61 fields · synced May 18, 2026
- EUDAMED 689bd082-25be-4c7d-811b-73c23f466e5f 61 fields · synced May 18, 2026