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CLEARsplint

EUDAMED

Class IIa (EU MDR)

Ref BES 98x25 Shoulder MagentaModel Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint DiscRef PCSRLK11Ref PCSREK11

by Astron Dental

Identity

Trade Name
CLEARsplint EUDAMED
CLEARsplint Economy Kit EUDAMED
Device Name
CLEARsplint EUDAMED
Model / Reference
Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc EUDAMED
BES 98x25 Shoulder Magenta EUDAMED
PCSRLK11 EUDAMED
PCSREK11 EUDAMED

Identifiers

Primary DI / UDI-DI
D810PCSD2598BESM1113D EUDAMED
D810PCSRLK115 EUDAMED
D810PCSREK113Y EUDAMED
Basic UDI-DI
++D810ClearsplintKM EUDAMED
Direct Marketing DI
D810PCSD2598BESM1113D 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 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

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Manufacturer

Manufacturer
Astron Dental
EUDAMED SRN
US-MF-000034006
Authorised Representative
Kentzler-Kaschner Dental GmbH DE-AR-000006367

Sources (3)

  • EUDAMED df11b46e-837f-4740-8c36-29ba1591ca5e 61 fields · synced Aug 4, 2026
  • EUDAMED da40c1fa-5ca6-4433-8205-efa839e6b429 61 fields · synced May 17, 2026
  • EUDAMED cec75c94-10bc-45f5-ad67-c0495e2d49ba 61 fields · synced May 19, 2026