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CLEARsplint Disc
EUDAMEDClass IIa (EU MDR)
Ref 95x16 Clover Edge Model Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint DiscRef 95x20 Clover Edge
Identity
- Trade Name
- CLEARsplint Disc EUDAMED
- Device Name
- CLEARsplint EUDAMED
- Model / Reference
- Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc EUDAMED95x16 Clover Edge EUDAMED95x20 Clover Edge EUDAMED
Identifiers
- Primary DI / UDI-DI
- D810PCSD1695Z111UH EUDAMEDD810PCSD95111TL EUDAMED
- Basic UDI-DI
- ++D810ClearsplintKM EUDAMED
- Direct Marketing DI
- D810PCSD1695Z111UH EUDAMEDD810PCSD95111TL 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 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 (2)
- EUDAMED d26dec33-8575-4082-aa24-03d288a9df34 61 fields · synced Jul 21, 2026
- EUDAMED 79b36239-f0ba-4373-83a0-af0687339c2d 61 fields · synced May 18, 2026