Identity
- Trade Name
- EssenSeal EUDAMEDFDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- EssenSeal EUDAMEDEssenSeal is a permanent endodontic sealer used with obturation points (made of gutta-percha) to seal tightly root canals. This device, a zinc oxide – eugenol based dental cement, consists of two parts, the powder and the liquid, which are mixed before use to form a paste of creamy consistency. FDA UDI
- Model / Reference
- 10246 EUDAMEDFDA UDI
- Description
- EssenSeal is a permanent endodontic sealer used with obturation points (made of gutta-percha) to seal tightly root canals. This device, a zinc oxide – eugenol based dental cement, consists of two parts, the powder and the liquid, which are mixed before use to form a paste of creamy consistency. FDA UDI
Identifiers
- Catalog Number
- EssenSeal FDA UDI
- Primary DI / UDI-DI
- 07640159162704 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640159162704 EUDAMED
- FDA Product Code
- EMB FDA UDI
- EMDN Code
- Q0101010202 ROOT CANAL 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
EssenSeal 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-07640159162704 | 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 87e03bac-3f0d-4c11-b303-4449cce72bdc 61 fields · synced Jun 19, 2026
- FDA UDI 5812961b-6109-41ef-930b-41156c6fdaf8 34 fields · synced May 30, 2026