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Dentalica Precision Cement-One

EUDAMED

Class IIa (EU MDR)

Ref PR0062CMWRef PR0062CMA

by B.J.M. Laboratories Ltd.

Identity

Trade Name
Dentalica Precision Cement-One EUDAMED
Device Name
Permanent Adhesive Cements EUDAMED
Model / Reference
PR0062CMW EUDAMED
PR0062CMA EUDAMED

Identifiers

Primary DI / UDI-DI
08057502150001 EUDAMED
08057502150018 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

Dentalica Precision Cement-One by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

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 (2)

  • EUDAMED a323d913-4a27-41d1-8969-37223d1532fa 61 fields · synced Jul 26, 2026
  • EUDAMED 0f7c167f-00bc-4d8b-bae3-0aaff0e5ca58 61 fields · synced May 18, 2026