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Clearfil Se Bond

EUDAMED

Class IIa (EU MDR)

Ref #1970-EUModel BondingsRef #3281-EU

by Kuraray Noritake Dental Inc. Kurashiki

Identity

Trade Name
CLEARFIL SE BOND EUDAMED
CLEARFIL SE BOND 2 BOND EUDAMED
Model / Reference
Bondings EUDAMED
#1970-EU EUDAMED
#3281-EU EUDAMED

Identifiers

Primary DI / UDI-DI
04582110779701 EUDAMED
04582110792816 EUDAMED
Basic UDI-DI
458211076Bonding0644C EUDAMED
458211076Bonding1954U 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 by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 (2)

  • EUDAMED b9e4dccf-1fd0-4d35-ae57-6343d5973700 61 fields · synced Jul 17, 2026
  • EUDAMED 142731d1-4432-4b7a-a3c0-9df9aac0f4a2 61 fields · synced May 18, 2026