Dental Zirconia Ceramics
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Upcera Dental Zirconia Blank For Aesthetic Restoration FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental Zirconia Ceramics EUDAMED
- Model / Reference
- Dental Zirconia Blank for Aesthetic Restoration EUDAMED/ EUDAMEDMT-S-D4 D100-12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941382226241 EUDAMEDFDA UDI
- Basic UDI-DI
- 694138229986JD EUDAMED
- Direct Marketing DI
- 06941382226241 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
Dental Zirconia Ceramics by Liaoning Upcera Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694138229986JD | 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 (2)
- EUDAMED f1bd3769-b18f-407b-9006-384480b6cb3c 61 fields · synced Jun 18, 2026
- FDA UDI d03599f5-be7a-4e84-9829-f88d3c8e0aaf 32 fields · synced May 30, 2026