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MOD. WACHS OPTIMA, rosa, 1, 5mm / 500g.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 74000
Identity
- Trade Name
- MOD. WACHS OPTIMA, rosa, 1,5mm / 500g. EUDAMEDNA FDA UDI
- Generic Name
- Denture clasp, metal, custom-made FDA UDI
- Device Name
- Optima EUDAMEDMODELLING WAX OPTIMA, pink, 1,5mm, 500g. FDA UDI
- Model / Reference
- 74000 EUDAMEDFDA UDI
- Description
- MODELLING WAX OPTIMA, pink, 1,5mm, 500g. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB74000 EUDAMEDEGEB74000 FDA UDI
- Basic UDI-DI
- 42518579OptimaLQ 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 OPTIMA, rosa, 1, 5mm / 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 | 42518579OptimaLQ | 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 a46aa0ec-7640-4743-9d5e-2c377c4d10d9 61 fields · synced Jul 20, 2026
- FDA UDI 39a362bc-a824-4b08-a017-8802aebc46e2 33 fields · synced May 30, 2026