Identity
- Trade Name
- DENTURE GINGIVA FLEXIBLE EUDAMED
- Device Name
- Dental Resins EUDAMED
- Model / Reference
- TMCAxx(x)yy(ww)(zzz(z)) EUDAMED
Identifiers
- Primary DI / UDI-DI
- D800TMCAxx(x)yy(ww)(zzz(z))0 EUDAMED
- Basic UDI-DI
- ++D800RES004001HY EUDAMED
- Direct Marketing DI
- D800TMCAxx(x)yy(ww)(zzz(z))0 EUDAMED
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Temporary dental crown/bridge
Denture Gingiva Flexible by Zirkonzahn Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D800RES004001HY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zirkonzahn SRL
- EUDAMED SRN
- IT-MF-000028795
Sources (1)
- EUDAMED 2d2b745f-f409-45c4-9980-557e45455c1e 61 fields · synced Jul 9, 2026