Identity
- Trade Name
- METALLFOLIENWACHS BRAUN EUDAMEDNA FDA UDI
- Generic Name
- Denture clasp, metal, custom-made FDA UDI
- Device Name
- Bissregistrierungswachs EUDAMEDMetal Foil Wax, brown, 60 pieces, 4mm FDA UDI
- Model / Reference
- 84200 EUDAMEDFDA UDI
- Description
- Metal Foil Wax, brown, 60 pieces, 4mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB84200 EUDAMEDEGEB84200 FDA UDI
- Basic UDI-DI
- 42518579BissregFoilFE EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Denture clasp, metal, custom-made FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone dental impression material
Metallfolienwachs Braun by Gebdi Dental-Products GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 42518579BissregFoilFE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- gebdi DENTAL-PRODUCTS GmbH
- EUDAMED SRN
- DE-MF-000005566
Sources (2)
- EUDAMED 4cca9efa-05c8-487d-a175-7a511b79a18f 61 fields · synced Jun 19, 2026
- FDA UDI a5f1dde4-99a2-4ea5-a59a-f0e8a1a8439f 33 fields · synced May 29, 2026