Identity
- Trade Name
- CERABALT K30 EUDAMEDFDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- LINGOT CERABALT K30 EUDAMED
- Model / Reference
- CERABALT K30 EUDAMED1103000 EUDAMEDIngots 15x8 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760357970025 EUDAMEDFDA UDI
- Basic UDI-DI
- 376035797K30JA EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cerabalt K30 by Bernard Cervos Societe — 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 | 376035797K30JA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bernard Cervos Societe
- EUDAMED SRN
- FR-MF-000016213
Sources (2)
- EUDAMED bad66a01-64a0-42a1-a602-d7f73e83e81d 61 fields · synced Jun 18, 2026
- FDA UDI 30ce9f27-994c-4199-aa68-1a971103d714 33 fields · synced May 29, 2026