Identity
- Trade Name
- Ceramir CAD/CAM C-BLOCK A2 EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, combination-material FDA UDI
- Device Name
- CAD/CAM BLOCK EUDAMED5pcs Ceramir CAD/CAM C-BLOCK A2 (12/14/18) FDA UDI
- Model / Reference
- 805190 EUDAMEDFDA UDI
- Description
- 5pcs Ceramir CAD/CAM C-BLOCK A2 (12/14/18) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046326641 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632BlockFA EUDAMED
- 510(k) Number
- K241131 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, combination-material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ceramir CAD/CAM C-BLOCK A2 by Edelweiss Dentistry Products 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 | 912004632BlockFA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- edelweiss dentistry products gmbh
- EUDAMED SRN
- AT-MF-000005413
Sources (2)
- EUDAMED 6b24e90c-4ca5-47c3-a38e-4580c56dc5e2 61 fields · synced Jul 18, 2026
- FDA UDI d0012499-1f41-478e-aa31-8478fb2ec07b 34 fields · synced May 30, 2026