Identity
- Trade Name
- CLEARFIL SE BOND PRIMER EUDAMED
- Model / Reference
- Bondings EUDAMED#1982-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110779824 EUDAMED
- Basic UDI-DI
- 458211076Bonding0644C EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Dentine bonding agent/set
Clearfil Se Bond Primer by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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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 | 458211076Bonding0644C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d5380efd-36a4-400d-8334-94ccb5a7c830 61 fields · synced Jul 12, 2026