Identity
- Trade Name
- OCCLUSION VD 45 L EUDAMEDedelweiss OCCLUSION 45 L FDA UDI
- Generic Name
- Dental veneer, professional FDA UDI
- Device Name
- Occlusion VD EUDAMED
- Model / Reference
- 13241 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046321813 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632Occlusion7Q EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental veneer, professional 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Occlusion Vd 45 L 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 | 912004632Occlusion7Q | 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
- edelweiss dentistry products gmbh
- EUDAMED SRN
- AT-MF-000005413
Sources (2)
- EUDAMED 1973ad53-ac3c-4996-bfe8-e2a1db985fac 61 fields · synced Jun 19, 2026
- FDA UDI 3fcdf00b-032a-42ed-860d-488db61abbf2 32 fields · synced May 30, 2026