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CLEARsplint Disc BES
EUDAMEDClass IIa (EU MDR)
Ref BES 98x16 Shoulder ClearModel Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc
Identity
- Trade Name
- CLEARsplint Disc BES EUDAMED
- Device Name
- CLEARsplint EUDAMED
- Model / Reference
- Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc EUDAMEDBES 98x16 Shoulder Clear EUDAMED
Identifiers
- Primary DI / UDI-DI
- D810PCSD169811169 EUDAMED
- Basic UDI-DI
- ++D810ClearsplintKM EUDAMED
- Direct Marketing DI
- D810PCSD169811169 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 Disc BES 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 bb8a4dc2-355b-4d5a-8b4a-fa001823f154 61 fields · synced Jun 18, 2026