Identity
- Trade Name
- Ena Shiny FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- ENA / ENAMEL PLUS SHINY EUDAMEDEna Shiny Composite Finishing Strips 100 pcs Nedium-Coarse Grain Strips "Narrow" FDA UDI
- Model / Reference
- ESSMS EUDAMEDFDA UDI
- Description
- Ena Shiny Composite Finishing Strips 100 pcs Nedium-Coarse Grain Strips "Narrow" FDA UDI
Identifiers
- Catalog Number
- ESSMS FDA UDI
- Primary DI / UDI-DI
- EMICESSMS1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1D2U4 EUDAMED
- FDA Product Code
- EHM FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental abrasive strip, single-use
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 d1bc6f22-84b5-4ffd-bdf7-cc3bb13aa66a 34 fields · synced Jun 18, 2026
- EUDAMED 095dbf34-c7bd-4654-ab4b-c42e5746a750 61 fields · synced Jun 18, 2026