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Zirconia Dental Ceramics
EUDAMEDClass IIa (EU MDR)
Ref ML-A3-SHT Cylinder(98×20)mmRef ML-B2-ST Cylinder(95×18)mmRef ML-B3-3D-plus Cylinder(98×12)mmRef ML-OM2-3D-plus Cylinder(98×25)mmRef ML-C3-UT Cylinder(95×14)mmRef OM2-ST Cylinder(98×12)mmRef ML-OM1-ST Cylinder(95×16)mmRef ML-OM2-SHT Cylinder(98×35)mmRef ML-D4-SHT Cylinder(98×12)mmRef ML-A2-3D-plus Cylinder(98×18)mmRef BL2-ST Cylinder(95×14)mmRef ML-BL1-3D-plus Cylinder(95×14)mmRef ML-A4-UT Cylinder(95×18)mmRef A1-ST Cylinder(98×18)mmRef ML-BL1-4D Cylinder(98×25)mmRef ML-D3-ST Cylinder(98×14)mmRef ML-A1-3D-plus Cylinder(98×25)mmRef BL2-SHT Cylinder(95×20)mmRef A3.5-SHT Cylinder(95×16)mmRef ML-A3.5-ST Cylinder(95×10)mmRef ML-D2-SHT Cylinder(98×10)mmRef ML-B2-ST Cylinder(98×16)mmRef C4-SHT Cylinder(95×25)mmRef ML-B1-4D Cylinder(95×20)mmRef ML-C2-UT Cylinder(95×18)mmRef ML-A1-3D-plus Cylinder(95×30)mmRef ML-C4-ST Cylinder(95×35)mmRef BL4-SHT Cylinder(95×25)mmRef C1-SHT Cylinder(98×10)mmRef ML-B3-SHT Cylinder(98×22)mmRef ML-D4-UT Cylinder(98×20)mmRef B3-ST Cylinder(98×10)mmRef B4-ST Cylinder(95×14)mmRef ML-A3.5-ST Cylinder(98×30)mmRef ML-A3-4D Cylinder(98×25)mmRef ML-A3.5-4D Cylinder(95×35)mmRef ML-B4-4D Cylinder(98×25)mmRef ML-BL2-UT Cylinder(98×30)mmRef ML-B3-4D Cylinder(98×35)mmRef ML-C4-UT Cylinder(95×30)mmRef ML-BL1-4D Cylinder(98×30)mmRef ML-B4-SHT Cylinder(95×22)mmRef ML-BL2-SHT Cylinder(95×12)mmRef B3-ST Cylinder(98×16)mmRef ML-B4-ST Cylinder(95×18)mmRef A2-SHT Cylinder(95×25)mmRef BL1-SHT Cylinder(95×16)mmRef ML-BL4-UT Cylinder(95×22)mmRef ML-C3-4D Cylinder(95×20)mmRef ML-B4-4D Cylinder(95×14)mmRef ML-A1-3D-plus Cylinder(95×18)mm
Identity
- Trade Name
- Zirconia Dental Ceramics EUDAMED
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- ML-A3-SHT Cylinder(98×20)mm EUDAMEDML-B2-ST Cylinder(95×18)mm EUDAMEDML-B3-3D-plus Cylinder(98×12)mm EUDAMEDML-OM2-3D-plus Cylinder(98×25)mm EUDAMEDML-C3-UT Cylinder(95×14)mm EUDAMEDOM2-ST Cylinder(98×12)mm EUDAMEDML-OM1-ST Cylinder(95×16)mm EUDAMEDML-OM2-SHT Cylinder(98×35)mm EUDAMEDML-D4-SHT Cylinder(98×12)mm EUDAMEDML-A2-3D-plus Cylinder(98×18)mm EUDAMEDBL2-ST Cylinder(95×14)mm EUDAMEDML-BL1-3D-plus Cylinder(95×14)mm EUDAMEDML-A4-UT Cylinder(95×18)mm EUDAMEDA1-ST Cylinder(98×18)mm EUDAMEDML-BL1-4D Cylinder(98×25)mm EUDAMEDML-D3-ST Cylinder(98×14)mm EUDAMEDML-A1-3D-plus Cylinder(98×25)mm EUDAMEDBL2-SHT Cylinder(95×20)mm EUDAMEDA3.5-SHT Cylinder(95×16)mm EUDAMEDML-A3.5-ST Cylinder(95×10)mm EUDAMEDML-D2-SHT Cylinder(98×10)mm EUDAMEDML-B2-ST Cylinder(98×16)mm EUDAMEDC4-SHT Cylinder(95×25)mm EUDAMEDML-B1-4D Cylinder(95×20)mm EUDAMEDML-C2-UT Cylinder(95×18)mm EUDAMEDML-A1-3D-plus Cylinder(95×30)mm EUDAMEDML-C4-ST Cylinder(95×35)mm EUDAMEDBL4-SHT Cylinder(95×25)mm EUDAMEDC1-SHT Cylinder(98×10)mm EUDAMEDML-B3-SHT Cylinder(98×22)mm EUDAMEDML-D4-UT Cylinder(98×20)mm EUDAMEDB3-ST Cylinder(98×10)mm EUDAMEDB4-ST Cylinder(95×14)mm EUDAMEDML-A3.5-ST Cylinder(98×30)mm EUDAMEDML-A3-4D Cylinder(98×25)mm EUDAMEDML-A3.5-4D Cylinder(95×35)mm EUDAMEDML-B4-4D Cylinder(98×25)mm EUDAMEDML-BL2-UT Cylinder(98×30)mm EUDAMEDML-B3-4D Cylinder(98×35)mm EUDAMEDML-C4-UT Cylinder(95×30)mm EUDAMEDML-BL1-4D Cylinder(98×30)mm EUDAMEDML-B4-SHT Cylinder(95×22)mm EUDAMEDML-BL2-SHT Cylinder(95×12)mm EUDAMEDB3-ST Cylinder(98×16)mm EUDAMEDML-B4-ST Cylinder(95×18)mm EUDAMEDA2-SHT Cylinder(95×25)mm EUDAMEDBL1-SHT Cylinder(95×16)mm EUDAMEDML-BL4-UT Cylinder(95×22)mm EUDAMEDML-C3-4D Cylinder(95×20)mm EUDAMEDML-B4-4D Cylinder(95×14)mm EUDAMEDML-A1-3D-plus Cylinder(95×18)mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942053593327 EUDAMED06942053589627 EUDAMED06941695403438 EUDAMED06941695405494 EUDAMED06942053599794 EUDAMED06942053582499 EUDAMED06942053591606 EUDAMED06942053596366 EUDAMED06942053595888 EUDAMED06941695402264 EUDAMED06942053583205 EUDAMED06941695405944 EUDAMED06942053598414 EUDAMED06942053579123 EUDAMED06941695410498 EUDAMED06942053591095 EUDAMED06941695402097 EUDAMED06942053587838 EUDAMED06942053584417 EUDAMED06942053588989 EUDAMED06942053595475 EUDAMED06942053589511 EUDAMED06942053586251 EUDAMED06941695407771 EUDAMED06942053599619 EUDAMED06941695402202 EUDAMED06942053590869 EUDAMED06942053588255 EUDAMED06942053585483 EUDAMED06942053594331 EUDAMED06941695400475 EUDAMED06942053580488 EUDAMED06942053580808 EUDAMED06942053588965 EUDAMED06941695407092 EUDAMED06941695407412 EUDAMED06941695408297 EUDAMED06941695401502 EUDAMED06941695408112 EUDAMED06941695400055 EUDAMED06941695410504 EUDAMED06942053594638 EUDAMED06942053596984 EUDAMED06942053580518 EUDAMED06942053590012 EUDAMED06942053584059 EUDAMED06942053587616 EUDAMED06941695401984 EUDAMED06941695408976 EUDAMED06941695408341 EUDAMED06941695402165 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69420535ZirconiaXV | 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 (51)
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