Identity
- Trade Name
- Zinc Oxide - 250g EUDAMEDFDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- Zinc Oxide -250g EUDAMEDZINC OXIDE - 250g (regular setting) Temporary filling and root canal sealing (mixed with Eugenol) FDA UDI
- Model / Reference
- 11432 EUDAMEDFDA UDI
- Description
- ZINC OXIDE - 250g (regular setting) Temporary filling and root canal sealing (mixed with Eugenol) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159162773 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640159162773 EUDAMED
- FDA Product Code
- EMB FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zinc Oxide - 250g by Produits Dentaires SA — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-07640159162773 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED 59f940b0-4261-498e-8360-7ce152c8f5a8 61 fields · synced Sep 17, 2026
- FDA UDI e2473b14-a3a2-4b46-84d7-af795605757d 34 fields · synced May 30, 2026