← Back to catalogue
Cercon ceram Kiss Artist Add-on Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5367190531Model Ceramics Procedure Pack
Identity
- Trade Name
- Cercon ceram Kiss Artist Add-on Kit EUDAMEDCercon® ceram Kiss FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Ceramics Procedure Pack EUDAMED5367190531 EUDAMEDCercon ceram Kiss Artist Add-on Kit FDA UDI
Identifiers
- Catalog Number
- 5367190531 FDA UDI
- Primary DI / UDI-DI
- +EDD153671905310 EUDAMEDEDD153671905310 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
Cercon ceram Kiss Artist Add-on 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DeguDent GmbH
- EUDAMED SRN
- DE-PR-000034763
Sources (2)
- EUDAMED 41311cb6-00ff-4737-b550-6c69571719e4 61 fields · synced Oct 5, 2026
- FDA UDI f80440a0-8dba-4328-92c8-e9e9b00beec0 35 fields · synced May 27, 2026