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Proclinic Expert Dual Resin Cement

EUDAMED

Class IIa (EU MDR)

Ref 78552

by B.J.M. Laboratories Ltd.

Identity

Trade Name
Proclinic Expert Dual Resin Cement EUDAMED
Device Name
Permanent Adhesive Cements EUDAMED
Model / Reference
78552 EUDAMED

Identifiers

Primary DI / UDI-DI
08434309041501 EUDAMED
Basic UDI-DI
72901150510005099 EUDAMED
EMDN Code
Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium 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 composite resin

Proclinic Expert Dual Resin Cement by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
IL-MF-000034121
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED f4f0d43e-e19f-4b52-bfff-ef9a1ec9ccdb 61 fields · synced Jun 19, 2026