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Cavex SiliconA Heavy Body
EUDAMEDClass IIa (EU MDR)
Ref AS52Model Dental Impression Material, Silicone Rubber
Identity
- Trade Name
- Cavex SiliconA Heavy Body EUDAMED
- Device Name
- Cavex SiliconA EUDAMED
- Model / Reference
- Dental Impression Material, Silicone Rubber EUDAMEDAS52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241AS520 EUDAMED
- Basic UDI-DI
- ++E241AS0068 EUDAMED
- Direct Marketing DI
- E241AS520 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
The Cavex SiliconA Heavy Body is a Class IIa medical device used for the impression of dental implants. It is designed to provide a durable and long-lasting impression material that can withstand the rigors of repeated use.
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Also classified as Silicone dental impression material.
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Manufacturer's product page: Cavex SiliconA & SiliconA Bite
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 | ++E241AS0068 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (1)
- EUDAMED f98ac076-a5c3-4cc3-a1a9-c132d6495a94 61 fields · synced Jul 31, 2026