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Ena Shiny
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref ESAModel Paste Diamond
by Micerium Spa
Identity
- Trade Name
- Ena Shiny FDA UDI
- Generic Name
- Professional dental abrasive material FDA UDI
- Device Name
- Shiny A-B / Paste Diamond EUDAMEDEna Shiny Shiny A 3 micron Diamond Paste 2 g FDA UDI
- Model / Reference
- ESA EUDAMEDFDA UDIPaste Diamond EUDAMED
- Description
- Ena Shiny Shiny A 3 micron Diamond Paste 2 g FDA UDI
Identifiers
- Catalog Number
- ESA FDA UDI
- Primary DI / UDI-DI
- EMICESA1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1D3U6 EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Professional dental abrasive material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2 Gram FDA UDI
Category: Professional dental abrasive material
Ena Shiny by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 88719de3-abd6-4304-aab9-54e9251d5a47 36 fields · synced Sep 18, 2026
- EUDAMED b8ca0a3f-34b3-42a0-8e38-bdce32a76dd7 61 fields · synced Sep 18, 2026