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MOD.WACHS SPEZIAL 1, 5mm, Sommer 500g.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 70811
Identity
- Trade Name
- MOD.WACHS SPEZIAL 1,5mm, Sommer 500g. EUDAMEDNA FDA UDI
- Generic Name
- Denture clasp, metal, custom-made FDA UDI
- Device Name
- Modellierwachs-Platten EUDAMEDModelling wax, pink, 1,5mm, 500g. - SPEZIAL SUMMER - FDA UDI
- Model / Reference
- 70811 EUDAMEDFDA UDI
- Description
- Modelling wax, pink, 1,5mm, 500g. - SPEZIAL SUMMER - FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB70811 EUDAMEDEGEB70811 FDA UDI
- Basic UDI-DI
- 42518579ModWachsPlaZR EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020203 OCCLUSAL WAXES 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
MOD.WACHS SPEZIAL 1, 5mm, Sommer 500g. by Gebdi Dental-Products GmbH — Class I — 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 | 42518579ModWachsPlaZR | 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 c5628984-861a-4a28-9e8b-afc8dc41df4d 61 fields · synced Jun 20, 2026
- FDA UDI 1f0fdc8c-b439-4d5e-9891-7d35f86e4b73 33 fields · synced May 30, 2026