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CLEARFIL SE BOND Introductory Kit

EUDAMED

Class IIa (EU MDR)

Ref #1975-EUModel Bondings

by Kuraray Noritake Dental Inc. Kurashiki

Identity

Trade Name
CLEARFIL SE BOND Introductory Kit EUDAMED
Model / Reference
Bondings EUDAMED
#1975-EU EUDAMED

Identifiers

Primary DI / UDI-DI
04582110779756 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 Introductory Kit 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 (1)

  • EUDAMED f9801ad1-8445-4a0c-9bbf-b2ef98fc2270 61 fields · synced Jul 15, 2026