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Duceragold Kiss Trial Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5360390100Model Ceramics Procedure Pack
Identity
- Trade Name
- Duceragold Kiss Trial Kit EUDAMEDDuceragold® Kiss FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Ceramics Procedure Pack EUDAMED5360390100 EUDAMEDDuceragold Kiss A3-Test Set 8x20g FDA UDI
Identifiers
- Catalog Number
- 5360390100 FDA UDI
- Primary DI / UDI-DI
- +EDD153603901000 EUDAMEDEDD153603901000 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
Duceragold Kiss Trial Kit 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 4103fba0-1bd2-469f-b855-c157a3b0edc8 61 fields · synced Jun 18, 2026
- FDA UDI bb638419-588f-4ea6-885f-c882b7ac6279 35 fields · synced May 30, 2026