Skip to content

Ena Shiny ESDX

by Micerium SpA

Ref ESDX

Ena Shiny ESDX is a dental abrasive disk (EU MDD Class IIa; FDA Class I; FDA product code EHJ, Disk, Abrasive) made by Micerium SpA, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-EMICESDX1) and listed in FDA GUDID since 3 Dec 2021 (UDI-DI EMICESDX1), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-EMICESDX1 Basic UDI-DI EMICESDX1UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICESDX1 UDI-DI Date3 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-EMICESDX1 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI EMICESDX1 listed 3 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EMICESDX1
  2. Registered EUDAMED B-EMICESDX1

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Ena Shiny
Generic name
Dental abrasive disk, single-use
Device name
Ena/Enamel Plus Shiny
Model / Ref / Catalog
ESDX
Primary DI / UDI-DI
EMICESDX1
Basic UDI-DI
B-EMICESDX1
FDA product code
EHJ
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dental abrasive disk, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6010
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI EMICESDX1: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental abrasive disk, single-use

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)