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Dental Lithium Disilicate Glass-Ceramics
EUDAMEDClass IIa (EU MDR)
Ref HT-C1 Cylinder(11×12.5)mmRef LT-B1 cuboid (18×15×13)mmRef HT-C3 Cylinder(10×12.5)mmRef LT-B4 Cylinder(13×12.5)mmRef LT-B2 cuboid (18×15×13)mmRef HT-B4 Cylinder(13×12.5)mmRef HT-C2 cuboid (18×15×13)mmRef HT-BL4 cuboid (18×15×13)mmRef HT-BL4 Cylinder(10×12.5)mmRef HT-D2 Cylinder(10×12.5)mmRef HT-C4 cuboid (18×15×13)mmRef HT-A3 Cylinder(11×12.5)mmRef LT-A1 Cylinder(10×12.5)mmRef LT-D3 Cylinder(13×12.5)mmRef LT-C1 Cylinder(13×12.5)mmRef HT-B2 Cylinder(11×12.5)mmRef HT-C2 Cylinder(11×12.5)mmRef LT-BL4 Cylinder(13×12.5)mmRef LT-D3 Cylinder(10×12.5)mmRef HT-B4 cuboid (18×15×13)mmRef HT-A3.5 Cylinder(11×12.5)mmRef HT-BL3 cuboid (18×15×13)mmRef HT-D3 Cylinder(10×12.5)mmRef HT-D2 Cylinder(13×12.5)mmRef LT-C4 Cylinder(13×12.5)mmRef HT-B1 Cylinder(13×12.5)mmRef HT-B1 cuboid (18×15×13)mmRef HT-BL2 cuboid (18×15×13)mmRef LT-D4 Cylinder(13×12.5)mmRef LT-BL4 Cylinder(10×12.5)mmRef LT-BL1 Cylinder(13×12.5)mmRef LT-A1 Cylinder(11×12.5)mmRef HT-B3 Cylinder(13×12.5)mmRef HT-A2 Cylinder(13×12.5)mmRef LT-B3 Cylinder(11×12.5)mmRef LT-C3 cuboid (18×15×13)mmRef HT-C4 Cylinder(13×12.5)mmRef LT-C2 Cylinder(13×12.5)mmRef LT-A2 Cylinder(10×12.5)mmRef HT-A3.5 Cylinder(13×12.5)mmRef HT-A4 Cylinder(10×12.5)mmRef HT-A1 Cylinder(11×12.5)mmRef HT-BL1 Cylinder(13×12.5)mmRef HT-BL4 Cylinder(13×12.5)mmRef LT-B3 cuboid (18×15×13)mmRef HT-BL1 cuboid (18×15×13)mmRef HT-B4 Cylinder(10×12.5)mmRef LT-BL1 cuboid (18×15×13)mmRef LT-A3.5 Cylinder(10×12.5)mmRef LT-C3 Cylinder(10×12.5)mmRef LT-BL2 cuboid (18×15×13)mm
Identity
- Trade Name
- Dental Lithium Disilicate Glass-Ceramics EUDAMED
- Device Name
- Dental Glass Ceramics EUDAMED
- Model / Reference
- HT-C1 Cylinder(11×12.5)mm EUDAMEDLT-B1 cuboid (18×15×13)mm EUDAMEDHT-C3 Cylinder(10×12.5)mm EUDAMEDLT-B4 Cylinder(13×12.5)mm EUDAMEDLT-B2 cuboid (18×15×13)mm EUDAMEDHT-B4 Cylinder(13×12.5)mm EUDAMEDHT-C2 cuboid (18×15×13)mm EUDAMEDHT-BL4 cuboid (18×15×13)mm EUDAMEDHT-BL4 Cylinder(10×12.5)mm EUDAMEDHT-D2 Cylinder(10×12.5)mm EUDAMEDHT-C4 cuboid (18×15×13)mm EUDAMEDHT-A3 Cylinder(11×12.5)mm EUDAMEDLT-A1 Cylinder(10×12.5)mm EUDAMEDLT-D3 Cylinder(13×12.5)mm EUDAMEDLT-C1 Cylinder(13×12.5)mm EUDAMEDHT-B2 Cylinder(11×12.5)mm EUDAMEDHT-C2 Cylinder(11×12.5)mm EUDAMEDLT-BL4 Cylinder(13×12.5)mm EUDAMEDLT-D3 Cylinder(10×12.5)mm EUDAMEDHT-B4 cuboid (18×15×13)mm EUDAMEDHT-A3.5 Cylinder(11×12.5)mm EUDAMEDHT-BL3 cuboid (18×15×13)mm EUDAMEDHT-D3 Cylinder(10×12.5)mm EUDAMEDHT-D2 Cylinder(13×12.5)mm EUDAMEDLT-C4 Cylinder(13×12.5)mm EUDAMEDHT-B1 Cylinder(13×12.5)mm EUDAMEDHT-B1 cuboid (18×15×13)mm EUDAMEDHT-BL2 cuboid (18×15×13)mm EUDAMEDLT-D4 Cylinder(13×12.5)mm EUDAMEDLT-BL4 Cylinder(10×12.5)mm EUDAMEDLT-BL1 Cylinder(13×12.5)mm EUDAMEDLT-A1 Cylinder(11×12.5)mm EUDAMEDHT-B3 Cylinder(13×12.5)mm EUDAMEDHT-A2 Cylinder(13×12.5)mm EUDAMEDLT-B3 Cylinder(11×12.5)mm EUDAMEDLT-C3 cuboid (18×15×13)mm EUDAMEDHT-C4 Cylinder(13×12.5)mm EUDAMEDLT-C2 Cylinder(13×12.5)mm EUDAMEDLT-A2 Cylinder(10×12.5)mm EUDAMEDHT-A3.5 Cylinder(13×12.5)mm EUDAMEDHT-A4 Cylinder(10×12.5)mm EUDAMEDHT-A1 Cylinder(11×12.5)mm EUDAMEDHT-BL1 Cylinder(13×12.5)mm EUDAMEDHT-BL4 Cylinder(13×12.5)mm EUDAMEDLT-B3 cuboid (18×15×13)mm EUDAMEDHT-BL1 cuboid (18×15×13)mm EUDAMEDHT-B4 Cylinder(10×12.5)mm EUDAMEDLT-BL1 cuboid (18×15×13)mm EUDAMEDLT-A3.5 Cylinder(10×12.5)mm EUDAMEDLT-C3 Cylinder(10×12.5)mm EUDAMEDLT-BL2 cuboid (18×15×13)mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942445563822 EUDAMED06942445562986 EUDAMED06942445563440 EUDAMED06942445564010 EUDAMED06942445562993 EUDAMED06942445564218 EUDAMED06942445562832 EUDAMED06942445562924 EUDAMED06942445563525 EUDAMED06942445563464 EUDAMED06942445562856 EUDAMED06942445563754 EUDAMED06942445563136 EUDAMED06942445564072 EUDAMED06942445564027 EUDAMED06942445563792 EUDAMED06942445563839 EUDAMED06942445564126 EUDAMED06942445563273 EUDAMED06942445562818 EUDAMED06942445563761 EUDAMED06942445562917 EUDAMED06942445563471 EUDAMED06942445564263 EUDAMED06942445564058 EUDAMED06942445564188 EUDAMED06942445562788 EUDAMED06942445562900 EUDAMED06942445564089 EUDAMED06942445563327 EUDAMED06942445564096 EUDAMED06942445563532 EUDAMED06942445564201 EUDAMED06942445564140 EUDAMED06942445563600 EUDAMED06942445563044 EUDAMED06942445564256 EUDAMED06942445564034 EUDAMED06942445563143 EUDAMED06942445564164 EUDAMED06942445563372 EUDAMED06942445563730 EUDAMED06942445564294 EUDAMED06942445564324 EUDAMED06942445563006 EUDAMED06942445562894 EUDAMED06942445563419 EUDAMED06942445563099 EUDAMED06942445563167 EUDAMED06942445563242 EUDAMED06942445563105 EUDAMED
- Basic UDI-DI
- 69420535Glass57 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
Dental Lithium Disilicate Glass-Ceramics by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69420535Glass57 | 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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