Identity
- Trade Name
- KP-Root SP EUDAMED
- Device Name
- Injectable Root Canal Sealer EUDAMED
- Model / Reference
- SP-1 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975384335298 EUDAMED
- Basic UDI-DI
- 69753843317Z3 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
KP-Root SP by Guilin Kevin Peter Technology Co., Ltd. — 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 | 69753843317Z3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Kevin Peter Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022934
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED a34eb2b1-12e4-4a42-96dd-f69f3ff4edf5 61 fields · synced Jul 30, 2026