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Syntette Orbis
EUDAMEDClass I (EU MDR)
Ref 215-216PDOLMModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus
Identity
- Trade Name
- Syntette Orbis EUDAMED
- Device Name
- Periodontal hand instrument EUDAMED
- Model / Reference
- 215-216PDOLM EUDAMEDDental hand instrument, curette for the removal of the subgingival and supragingival calculus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706528 EUDAMED
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311706528 EUDAMED
- Direct Marketing DI
- 06438311706528 EUDAMED
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, 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
Syntette 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 | 6438311PERIO1r06S | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311PERIO1r06S | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED c4d53c8a-85fa-423d-be56-ca39c98806f5 61 fields · synced Jun 18, 2026
- EUDAMED ac423f6a-471e-4309-b31b-8822d3797f57 61 fields · synced May 19, 2026