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Dental Lithium Disilicate Glass Ceramics
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MD 0402 DentModel Dental Lithium Disilicate Glass Ceramic Block(CAD/CAM)
Identity
- Trade Name
- Dental Lithium Disilicate Glass Ceramics EUDAMEDDental Lithium Disilicate Glass Ceramic Block(Up.CAD Series) FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Dental Lithium Disilicate Glass Ceramics EUDAMED
- Model / Reference
- Dental Lithium Disilicate Glass Ceramic Block(CAD/CAM) EUDAMEDMD 0402 Dent EUDAMEDHT VBL1-R(18-15-13) FDA UDILT VC1-R(18-15-13) FDA UDILT VB1-R(18-15-13) FDA UDILT VB2-R(18-15-13) FDA UDIHT VA3-R(18-15-13) FDA UDIHT VC4-R(18-15-13) FDA UDILT VBL3-R(18-15-13) FDA UDIHT VD3-R(18-15-13) FDA UDILT VA2-R(18-15-13) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941382249561 EUDAMEDFDA UDI06941382249516 EUDAMEDFDA UDI06941382249646 EUDAMEDFDA UDI06941382249608 EUDAMEDFDA UDI06941382249615 EUDAMEDFDA UDI06941382249370 EUDAMEDFDA UDI06941382249479 EUDAMEDFDA UDI06941382249738 EUDAMEDFDA UDI06941382249493 EUDAMEDFDA UDI
- Basic UDI-DI
- 694138229981J3 EUDAMED
- Direct Marketing DI
- 06941382249561 EUDAMED06941382249493 EUDAMED06941382249608 EUDAMED06941382249646 EUDAMED06941382249370 EUDAMED06941382249516 EUDAMED06941382249738 EUDAMED06941382249479 EUDAMED06941382249615 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Partial denture
Dental Lithium Disilicate Glass Ceramics by Liaoning Upcera Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Partial denture.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694138229981J3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Liaoning Upcera Co Ltd
- EUDAMED SRN
- CN-MF-000013088
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (18)
- EUDAMED ed5eef7e-ea5e-4d41-9cd0-39ff551c398b 61 fields · synced Oct 7, 2026
- FDA UDI 141db939-919f-4f10-a9f9-f4a58981c150 32 fields · synced May 29, 2026
- FDA UDI b75bfe62-8802-4e1f-be84-025f7eb98c20 32 fields · synced May 29, 2026
- FDA UDI 15b69afa-61d6-40b7-9fda-3dc49a1105b5 32 fields · synced May 29, 2026
- FDA UDI 66310ec0-c9f4-4645-ba1b-f336c874bcb1 32 fields · synced May 30, 2026
- FDA UDI fdc9a933-ed79-43e0-81c7-16bda254e28e 32 fields · synced May 30, 2026
- FDA UDI 94733d73-f1f9-43e5-9230-4563d4660eff 32 fields · synced May 30, 2026
- FDA UDI 3c84a187-0ca9-4298-8dfb-ae8d75496824 32 fields · synced May 30, 2026
- FDA UDI 3d6e11bf-2336-4fd2-87e3-7491d16c576f 32 fields · synced May 30, 2026
- FDA UDI 5d9011c1-4127-409d-945b-92f1b7da1e87 32 fields · synced May 30, 2026
- EUDAMED 00d16e3b-e2e3-40c7-b33d-105390cf25d9 61 fields · synced Jul 8, 2026
- EUDAMED 7f57c436-8521-4cd3-82e3-d7af7794384b 61 fields · synced Jul 9, 2026
- EUDAMED 5046ece7-2ad0-40c4-8dde-92d873881bed 61 fields · synced Jul 10, 2026
- EUDAMED 684fb599-3de6-49ba-baaa-afde69250417 61 fields · synced Jul 11, 2026
- EUDAMED cae1bd47-5873-4c61-a1d1-1f0704d03b32 61 fields · synced Jul 15, 2026
- EUDAMED ec14949b-a649-40c5-83b6-1699d9cf2802 61 fields · synced Jul 16, 2026
- EUDAMED 3f11bc39-ce0a-477b-9bfe-b254559b7438 61 fields · synced Jul 31, 2026
- EUDAMED 3c784ca5-c786-45b0-8334-ffb6ae19be62 61 fields · synced Oct 7, 2026