Dental Filling/Restorative Polymer Based Block
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Tooth Shade Resin Material FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Dental Filling/Restorative Polymer Based Block EUDAMED
- Model / Reference
- Dental Filling/Restorative Polymer Based Block EUDAMED/ EUDAMEDHT-M-A1-D(98-20) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941382252011 EUDAMEDFDA UDI
- Basic UDI-DI
- 694138229983J7 EUDAMED
- Direct Marketing DI
- 06941382252011 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Italy 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 Filling/Restorative Polymer Based Block by Liaoning Upcera Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 694138229983J7 | 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 a473a2ad-ca54-4af8-84d0-0987ac341546 61 fields · synced Oct 6, 2026
- FDA UDI d924f791-2e06-4c56-a5cd-fcd49c43e78a 32 fields · synced May 30, 2026