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Cavex Temporary Cement
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref CE090Model Temporary Dental Cements
Identity
- Trade Name
- Cavex Temporary Cement EUDAMEDFDA UDI
- Generic Name
- Temporary dental filling material FDA UDI
- Device Name
- Cavex Temporary Cement EUDAMEDDental Cement FDA UDI
- Model / Reference
- Temporary Dental Cements EUDAMEDCE090 EUDAMEDFDA UDI
- Description
- Dental Cement FDA UDI
Identifiers
- Catalog Number
- CE090 FDA UDI
- Primary DI / UDI-DI
- E241CE0900 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E241CE090PC EUDAMED
- 510(k) Number
- K003791 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Temporary dental filling material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 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
Yes
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
Cavex Temporary Cement by Cavex Holland BV — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K003791 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E241CE090PC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
- EUDAMED SRN
- NL-MF-000000423
Sources (3)
- EUDAMED 85fdcd9d-6ea2-4538-822b-eb2776249972 61 fields · synced Jul 19, 2026
- FDA UDI a32a3cf9-1ecb-4581-b49b-552fa4fa01bf 38 fields · synced May 30, 2026
- FDA 510(k) K003791 1 fields · synced May 18, 2026