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CLEARsplint Disc BES
EUDAMEDClass IIa (EU MDR)
Ref BES 98x25 Shoulder BlueModel Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint DiscRef BES 95x25 Clover EdgeRef BES 95x20 Clover Edge BlueRef BES 98x20 Shoulder BlueRef BES 98x25 Shoulder Clear
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 98x25 Shoulder Blue EUDAMEDBES 95x25 Clover Edge EUDAMEDBES 95x20 Clover Edge Blue EUDAMEDBES 98x20 Shoulder Blue EUDAMEDBES 98x25 Shoulder Clear EUDAMED
Identifiers
- Primary DI / UDI-DI
- D810PCSD2598BESB111YV EUDAMEDD810PCSD2595ZBES119M EUDAMEDD810PCSD2598BESB11158 EUDAMEDD810PCSD2098BESB111UC EUDAMEDD810PCSD2598BES1114Y EUDAMED
- Basic UDI-DI
- ++D810ClearsplintKM EUDAMED
- Direct Marketing DI
- D810PCSD2598BESB111YV EUDAMEDD810PCSD2595ZBES119M EUDAMEDD810PCSD2598BESB11158 EUDAMEDD810PCSD2098BESB111UC EUDAMEDD810PCSD2598BES1114Y 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 (5)
- EUDAMED f9d0a488-2100-4850-bc89-c45c714a174a 61 fields · synced Sep 17, 2026
- EUDAMED f9779577-1aab-49b4-b530-ed323c15ac12 61 fields · synced May 17, 2026
- EUDAMED 24cfa72a-fd62-4902-9063-33c011956052 61 fields · synced May 17, 2026
- EUDAMED fba4973e-5902-4632-94a6-836994ca5dd1 61 fields · synced May 19, 2026
- EUDAMED 8c0b34a6-1f2f-4489-a9bf-49f87848595c 61 fields · synced May 19, 2026