Identity
- Trade Name
- Ena Shiny FDA UDI
- Generic Name
- Dental abrasive disk, single-use FDA UDI
- Device Name
- ENA / ENAMEL PLUS SHINY EUDAMEDEna Shiny F 30 pcs. Felt Wheels - Composite Polishing Max speed 10.000 rpm FDA UDI
- Model / Reference
- ESF EUDAMEDFDA UDI
- Description
- Ena Shiny F 30 pcs. Felt Wheels - Composite Polishing Max speed 10.000 rpm FDA UDI
Identifiers
- Catalog Number
- ESF FDA UDI
- Primary DI / UDI-DI
- EMICESF1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1D2U4 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive disk, 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 disk, single-use
Ena Shiny by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive disk, single-use.
- PRAXIS — TDV DENTAL LTDA · Class I
- FlexiDisc Regular 3/4 Coarse — Cosmedent, Inc. · Class I
- SeptoWheels PX Kit: 12 wheels + 1 mandrel snap on — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- PRAXIS — TDV DENTAL LTDA · Class I
- FlexiDisc Mini Starter Kit 3/8 — Cosmedent, Inc. · Class I
- PRAXIS — TDV DENTAL LTDA · Class I
- PRAXIS — TDV DENTAL LTDA · Class I
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 0840363f-8d2c-49e8-94c3-70a7f9a07159 34 fields · synced Jun 19, 2026
- EUDAMED c94fc7a0-4bb8-4c6f-ad71-d7164b2ce9a0 61 fields · synced Jun 19, 2026