Identity
- Trade Name
- Mollosil plus 50 ml Kartusche EUDAMED
- Device Name
- Zahnprothesenunterfütterung, weich EUDAMED
- Model / Reference
- 02439 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET024391 EUDAMED
- Basic UDI-DI
- ++EDET0095Q EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Mollosil plus 50 ml Kartusche by DETAX GmbH & Co. KG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162654 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++EDET0095Q | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (2)
- EUDAMED e1400733-ec27-4b56-b293-d195c703c990 61 fields · synced Oct 5, 2026
- FDA 510(k) K162654 1 fields · synced May 18, 2026