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Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 805197
Identity
- Trade Name
- Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, combination-material FDA UDI
- Device Name
- CAD/CAM BLOCK EUDAMED5pcs Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel (12/14/18) FDA UDI
- Model / Reference
- 805197 EUDAMEDFDA UDI
- Description
- 5pcs Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel (12/14/18) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046326726 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632iBlockSK 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 i-BLOCK (øL) Universal Enamel by Edelweiss Dentistry Products Gmbh — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 912004632iBlockSK | 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 1ca0afed-e88b-49d7-88f3-87d3ddab3681 61 fields · synced Jul 15, 2026
- FDA UDI c8285b26-e6b7-42c7-b0cb-b2fa854afc1c 34 fields · synced May 29, 2026