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Zirconia Dental Ceramics
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ML-C3-4D Cylinder（98×20）mm
Identity
- Trade Name
- Zirconia Dental Ceramics EUDAMED
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- ML-C3-4D Cylinder（98×20）mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941695408877 EUDAMED
- Basic UDI-DI
- 69420535ZirconiaXV 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 by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214005 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69420535ZirconiaXV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yurucheng Dental Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000011505
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 505236e2-b5f9-4174-b361-e431b20e42be 61 fields · synced Jun 19, 2026
- FDA 510(k) K214005 1 fields · synced May 18, 2026