Identity
- Trade Name
- Pulp Canal Sealer EUDAMED
- Device Name
- Pulp Canal Sealer EUDAMED
- Model / Reference
- 33639 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055165082806 EUDAMED
- Basic UDI-DI
- 80515118720000055K EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental coating, tooth-desensitizing
Pulp Canal Sealer by Kerr Italia Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80515118720000055K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kerr Italia Srl
- EUDAMED SRN
- IT-MF-000007768
Sources (1)
- EUDAMED 1192111d-1b7d-4b20-810d-8c361d24626c 61 fields · synced Jun 18, 2026