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CALXYL® Dentin 10
EUDAMEDClass IIa (EU MDR)
Ref 10004100Model CALXYL® 20g
by OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH
Identity
- Trade Name
- CALXYL® Dentin 10 EUDAMED
- Device Name
- CALXYL® EUDAMED
- Model / Reference
- CALXYL® 20g EUDAMED10004100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260741310080 EUDAMED
- Basic UDI-DI
- 426074131-CALXYL-OCO-B9 EUDAMED
- Direct Marketing DI
- 04260741310080 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Dental coating, tooth-desensitizing
CALXYL® Dentin 10 by OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH — Class IIa — MDR — listed in EUDAMED
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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 | 426074131-CALXYL-OCO-B9 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000012362
Sources (1)
- EUDAMED 98b068c2-b0ae-4e96-8cbb-5b21dbd38271 61 fields · synced Jul 15, 2026