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Zirconia Dental Ceramics

EUDAMED

Class IIa (EU MDR)

Ref Multilayer ML-A2-DY (89×71×20)mm

by Shenzhen Yurucheng Dental Materials Co., Ltd.

Identity

Trade Name
Zirconia Dental Ceramics EUDAMED
Device Name
Zirconia Dental Ceramics EUDAMED
Model / Reference
Multilayer ML-A2-DY (89×71×20)mm EUDAMED

Identifiers

Primary DI / UDI-DI
06942053550283 EUDAMED
Basic UDI-DI
B-06942053550283 EUDAMED
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain 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

Zirconia Dental Ceramics is a high-performance medical device used in dental implant placement, providing precise control and minimal invasiveness. By leveraging advanced ceramic technology, this device offers unparalleled success rates for patients seeking to enhance the beauty and functionality of their smile.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000011505
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED f79e8183-0630-44e8-8078-6442a100e118 61 fields · synced Jul 30, 2026