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MTA Plus Aqua

EUDAMED

Class IIa (EU MDR)

Ref 40053Model Sealers

by Prevest Denpro Limited

Identity

Trade Name
MTA Plus Aqua EUDAMED
Device Name
MTA Plus Aqua EUDAMED
Model / Reference
Sealers EUDAMED
40053 EUDAMED

Identifiers

Primary DI / UDI-DI
+D9674005302 EUDAMED
Basic UDI-DI
B-+D9674005302 EUDAMED
EMDN Code
Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Calcium hydroxide dental cement

MTA Plus Aqua by Prevest Denpro Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Calcium hydroxide dental cement.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
IN-MF-000011546
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED fb41e28f-fa7a-427a-b776-d6930de5284c 61 fields · synced Jul 11, 2026