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Ena HRI ® EHRFUD3

by Micerium SpA

Ref EHRFUD3Model Light Curing Composite 6b1

Ena HRI ® EHRFUD3 is a device classified as Class IIa in the EU and Class II in the US made by Micerium SpA, registered in EUDAMED on 28 May 2026 (Basic UDI-DI ++EMICFAM1AE6B1FV), cleared under FDA 510(k) K062906 on 17 Nov 2006 and listed in FDA GUDID since 21 Nov 2016 (UDI-DI EMICEHRFUD31), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062906

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM1AE6B1FV Basic UDI-DI EMICEHRFUD31UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICEHRFUD31 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062906 Date17 Nov 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM1AE6B1FV registered 28 May 2026 Active
  • FDA 510(k) K062906 decided 17 Nov 2006 Active
  • FDA GUDID UDI-DI EMICEHRFUD31 listed 21 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062906
  2. Listed FDA GUDID EMICEHRFUD31
  3. Registered EUDAMED ++EMICFAM1AE6B1FV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Ena HRI ®
Generic name
Dental composite resin
Device name
Name: Light Curing Composite Model: Flow
Model / Ref / Catalog
EHRFUD3, Light Curing Composite 6b1
Description
Ena HRi Flow UD3 2g Light Curing Composite
Primary DI / UDI-DI
EMICEHRFUD31
Basic UDI-DI
++EMICFAM1AE6B1FV
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 2 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Dental composite resin

Cleared under the same submission (K062906)

and 8 more cleared under K062906

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (22, all answered No)