Identity
- Trade Name
- Prophylaxis Pastes without Fluoride EUDAMED
- Device Name
- Prophy Paste EUDAMED
- Model / Reference
- 3500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055165042503 EUDAMED
- Basic UDI-DI
- 80515118710000865U EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Prophylaxis Pastes without Fluoride by Kerr Italia Srl — Class I — 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 | 80515118710000865U | Class I | Active |
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Manufacturer
- Manufacturer
- Kerr Italia Srl
- EUDAMED SRN
- IT-MF-000007768
Sources (1)
- EUDAMED 1f5cac42-6cb6-4cfa-9408-9f12b1a86dd5 61 fields · synced Jul 11, 2026