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edelweiss CAD/CAM T-BLOCK Universal Enamel
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 19100
Identity
- Trade Name
- edelweiss CAD/CAM T-BLOCK Universal Enamel EUDAMEDedelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) FDA UDI
- Generic Name
- Dental appliance fabrication material, combination-material FDA UDI
- Device Name
- CAD/CAM BLOCK EUDAMED5pcs edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) FDA UDI
- Model / Reference
- 19100 EUDAMEDFDA UDI
- Description
- 5pcs edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046322414 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
- Austria 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
edelweiss CAD/CAM T-BLOCK 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 | 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 d57b25f9-22c1-4c8e-b7eb-280c5e3f1d2a 61 fields · synced Jul 9, 2026
- FDA UDI 5b468e0d-f82f-4fc7-95c7-89528a014e53 34 fields · synced May 30, 2026