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Duralay

EUDAMED

Class I (EU MDR)

Ref Duralay 8oz Powder ClearModel Duralay Ref Duralay 8oz LiquidRef Durlay Laboratory Package RedRef Duralay 2oz Powder Clear

by Reliance Dental Manufacturing

Identity

Trade Name
Duralay EUDAMED
Device Name
Duralay EUDAMED
Model / Reference
Duralay EUDAMED
Duralay 8oz Powder Clear EUDAMED
Duralay 8oz Liquid EUDAMED
Durlay Laboratory Package Red EUDAMED
Duralay 2oz Powder Clear EUDAMED

Identifiers

Primary DI / UDI-DI
D9472249BC EUDAMED
D9472249C EUDAMED
D9472249A EUDAMED
D9472245C EUDAMED
Basic UDI-DI
++D947DuralayB3 EUDAMED
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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

Duralay by Reliance Dental Manufacturing — Class I — 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

Manufacturer
Reliance Dental Manufacturing
EUDAMED SRN
US-MF-000041470
Authorised Representative
Kentzler-Kaschner Dental GmbH DE-AR-000006367

Sources (4)

  • EUDAMED f2747884-f9f1-408c-9878-b22eed11a832 61 fields · synced Sep 17, 2026
  • EUDAMED a376e877-8190-44b1-b0dd-8df6501a4a67 61 fields · synced May 16, 2026
  • EUDAMED 556cc45c-0092-405d-90e3-cdf5f56130fa 61 fields · synced May 18, 2026
  • EUDAMED bfbf0ebc-55a3-4e17-a180-80217bd9d35a 61 fields · synced May 19, 2026