Identity
- Trade Name
- Ena Shiny FDA UDI
- Generic Name
- Dental mandrel FDA UDI
- Device Name
- Ena Shiny Shiny Mandrel RA 6 pcs Madrel - Discs FDA UDI
- Model / Reference
- ESFM FDA UDI
- Description
- Ena Shiny Shiny Mandrel RA 6 pcs Madrel - Discs FDA UDI
Identifiers
- Catalog Number
- ESFM FDA UDI
- Primary DI / UDI-DI
- EMICESFM1 FDA UDI
- FDA Product Code
- EHJ FDA UDI
- GMDN Term
- Dental mandrel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental mandrel
Ena Shiny by Micerium Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental mandrel.
- Preat — PREAT Corporation · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- Johnson-Promident — Young Innovations, Inc. · Class I
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (1)
- FDA UDI fb0964bd-ee10-462f-96f9-d9e6132f7503 34 fields · synced May 30, 2026