Identity
- Trade Name
- TOTALCEM EUDAMED
- Device Name
- Self-Etching Permanent Resin Cement EUDAMED
- Model / Reference
- MDN 1103 EUDAMEDTCEM3-VPTR EUDAMEDTCEM3-VPA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760260221115 EUDAMED03760260221122 EUDAMED
- Basic UDI-DI
- B-03760260221115 EUDAMEDB-03760260221122 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
Totalcem by Itena Clinical — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760260221115 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Itena Clinical
- EUDAMED SRN
- FR-MF-000011957
Sources (2)
- EUDAMED df5237f2-41ae-4218-9587-d6ec7af26182 61 fields · synced Jul 21, 2026
- EUDAMED ccc834bc-0b7f-4e8e-9a74-23969541c2c6 61 fields · synced Jul 21, 2026