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CLEARsplint Super Economy Kit
EUDAMEDClass IIa (EU MDR)
Ref PCSRSEK11Model Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc
Identity
- Trade Name
- CLEARsplint Super Economy Kit EUDAMED
- Device Name
- CLEARsplint EUDAMED
- Model / Reference
- Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc EUDAMEDPCSRSEK11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D810PCSRSEK11H6 EUDAMED
- Basic UDI-DI
- ++D810ClearsplintKM EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
CLEARsplint Super Economy Kit by Astron Dental — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++D810ClearsplintKM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astron Dental
- EUDAMED SRN
- US-MF-000034006
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (1)
- EUDAMED 658f247a-7622-4067-a254-982d1bc3b258 61 fields · synced Jul 21, 2026