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Ducera LFC - Stain Kit large
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5360290113Model Ceramics Procedure Pack
Identity
- Trade Name
- Ducera LFC - Stain Kit large EUDAMEDLFC FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Ceramics Procedure Pack EUDAMED5360290113 EUDAMEDLFC-Stain Kit (large) FDA UDI
Identifiers
- Catalog Number
- 5360290113 FDA UDI
- Primary DI / UDI-DI
- +EDD153602901130 EUDAMEDEDD153602901130 FDA UDI
- Basic UDI-DI
- ++EDD1PPCERAMICSYG EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY 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
- Medical Purpose
- This procedure packs are intended to be used for fixed dental prosthetic restorations. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Ducera LFC - Stain Kit large by DeguDent GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++EDD1PPCERAMICSYG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DeguDent GmbH
- EUDAMED SRN
- DE-PR-000034763
Sources (2)
- EUDAMED bcd3163b-9bf8-4a70-aa03-0df92a8dd18e 61 fields · synced Jun 20, 2026
- FDA UDI 204a0899-cdd7-461c-bcf8-503d1557d927 35 fields · synced May 30, 2026