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CLEARFIL Universal Bond Quick 2 Bottle Trial

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref #4045-EUModel Bondings

by Kuraray Noritake Dental Inc. Kurashiki

Identity

Trade Name
CLEARFIL Universal Bond Quick 2　Bottle Trial EUDAMED
Model / Reference
Bondings EUDAMED
#4045-EU EUDAMED

Identifiers

Primary DI / UDI-DI
04582110800450 EUDAMED
Basic UDI-DI
458211076BondingHC 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 Universal Bond Quick 2 Bottle Trial by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

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 5a914c73-a4d9-4fc6-811a-7ce9c26bb05c 61 fields · synced Jul 27, 2026
  • FDA 510(k) K231039 1 fields · synced May 18, 2026