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Shiny Kit with bond&etch
EUDAMEDClass IIa (EU MDR)
Ref CHB2Model Cement with bonding
Identity
- Trade Name
- Shiny Kit with bond&etch EUDAMED
- Device Name
- Ena Cem Procedural EUDAMED
- Model / Reference
- Cement with bonding EUDAMEDCHB2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EMICCHB21 EUDAMED
- Basic UDI-DI
- ++EMICFAM1ACEMKL8 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Luting composite,for cementation of posts and core build-ups, for luting of ceramic and composite inlays, onlays veneers and crowns. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Dental composite resin
Shiny Kit with bond&etch by Micerium S.p.A. — 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 | ++EMICFAM1ACEMKL8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-PR-000025624
Sources (1)
- EUDAMED b9556d64-33c2-4ce0-8c3a-a9e920220000 61 fields · synced Jul 12, 2026