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Cavex Cream Alginate Fast Set 20x500g
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref AA605Model Cavex Alginate Impression Materials510(k) K151535
Identity
- Trade Name
- Cavex Cream Alginate Fast Set 20x500g EUDAMED
- Model / Reference
- Cavex Alginate Impression Materials EUDAMEDAA605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E241AA6051 EUDAMED
- Basic UDI-DI
- ++E241AA000LX EUDAMED
- Direct Marketing DI
- E241AA6051 EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
Classification
- Device Class
- Class I 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
Cavex Cream Alginate Fast Set 20x500g by Cavex Holland BV — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: Cavex Cream
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151535 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++E241AA000LX | Class I | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED ff705db7-e9a4-443d-9f95-3dc9dc277f52 85 fields · synced Jun 18, 2026
- FDA 510(k) K151535 1 fields · synced May 18, 2026