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Durabase Soft
EUDAMEDClass I (EU MDR)
Ref Durabase Soft 4oz LiquidModel Durabase SoftRef Durabase Soft 4oz Powder
Identity
- Trade Name
- Durabase Soft EUDAMED
- Device Name
- Durabase Soft 4oz Liquid EUDAMEDDurabase Soft 4oz Powder EUDAMED
- Model / Reference
- Durabase Soft EUDAMEDDurabase Soft 4oz Liquid EUDAMEDDurabase Soft 4oz Powder EUDAMED
Identifiers
- Primary DI / UDI-DI
- D9471508 EUDAMEDD9471507 EUDAMED
- Basic UDI-DI
- B-D9471508 EUDAMEDB-D9471507 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Silicone dental impression material
Durabase Soft by Reliance Dental Manufacturing — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D9471508 | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
- EUDAMED SRN
- US-MF-000041470
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (2)
- EUDAMED 88c759fa-13bd-427c-8e50-71c256afb3a8 61 fields · synced Jul 28, 2026
- EUDAMED ba00006f-ef41-471e-9824-b577b558dd63 61 fields · synced May 18, 2026