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DUROSIL KIT - Durosil L + Durosil S + Paste Hardener
EUDAMEDClass I (EU MDR)
Ref PRD.01.10004
Identity
- Trade Name
- DUROSIL KIT - Durosil L + Durosil S + Paste Hardener EUDAMED
- Device Name
- C SILICONE EUDAMED
- Model / Reference
- PRD.01.10004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260296271799 EUDAMED
- Basic UDI-DI
- 426029627CSIL017X EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I 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
Category: Silicone dental impression material
DUROSIL KIT - Durosil L + Durosil S + Paste Hardener by President Dental GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
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 | 426029627CSIL017X | Class I | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (1)
- EUDAMED ca4de51e-567a-4804-a526-6b9d37b7eb51 61 fields · synced Jul 24, 2026