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Cavex Alginate Impressional Fast Set 20x500g
EUDAMEDFDA UDIClass I (EU MDR)
Ref AA097Model Cavex Alginate Impression Materials
Identity
- Trade Name
- Cavex Alginate Impressional Fast Set 20x500g EUDAMEDCavex Impressional Fast Set FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- Dental Alginate Impression material FDA UDI
- Model / Reference
- Cavex Alginate Impression Materials EUDAMEDAA097 EUDAMEDFDA UDI
- Description
- Dental Alginate Impression material FDA UDI
Identifiers
- Catalog Number
- AA097 FDA UDI
- Primary DI / UDI-DI
- E241AA0971 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E241AA000LX EUDAMED
- Direct Marketing DI
- E241AA0971 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
- GMDN Term
- Alginate dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Weight — 10 Kilogram FDA UDI
Cavex Alginate Impressional Fast Set 20x500g by Cavex Holland BV — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Cavex Impressional
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E241AA000LX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (2)
- EUDAMED ea4b1101-bcec-4077-b798-293ebbe6900c 61 fields · synced Aug 3, 2026
- FDA UDI 0af3a872-b417-4484-a69a-5a8d1d1c7f15 37 fields · synced May 30, 2026