Identity
- Trade Name
- TOTALCEM EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Self-etching permanent resin cement EUDAMED
- Model / Reference
- TTLCEM-A2 EUDAMEDA2 FDA UDI
Identifiers
- Catalog Number
- TTLCEM-A2 FDA UDI
- Primary DI / UDI-DI
- 03760260221009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760260221009 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- France 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
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
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
Category: Dental composite resin
Totalcem by Itena Clinical — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760260221009 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Itena Clinical
- EUDAMED SRN
- FR-MF-000011957
Sources (2)
- EUDAMED c9eab182-541f-41af-a55f-bdca0d4af5ce 61 fields · synced Jul 11, 2026
- FDA UDI ed61b101-3a29-4887-94e9-0889f59102be 33 fields · synced May 30, 2026