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Ena Cem Hf Cpc

by Micerium SpA

Ref CPC

Ena Cem Hf Cpc is a device classified as Class IIa in the EU and Class II in the US made by Micerium SpA, registered in EUDAMED on 26 May 2026 (Basic UDI-DI ++EMICFAM1ACEM7A), cleared under FDA 510(k) K062355 on 27 Dec 2006 and listed in FDA GUDID since 3 Apr 2025 (UDI-DI EMICCPC1), 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) K062355

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++EMICFAM1ACEM7A Basic UDI-DI EMICCPC1UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICCPC1 UDI-DI Date3 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062355 Date27 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM1ACEM7A registered 26 May 2026 Active
  • FDA 510(k) K062355 decided 27 Dec 2006 Active
  • FDA GUDID UDI-DI EMICCPC1 listed 3 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062355
  2. Listed FDA GUDID EMICCPC1
  3. Registered EUDAMED ++EMICFAM1ACEM7A

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  • Withdrawn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 Cem Hf
Generic name
Dental composite resin
Device name
Name: ENA CEM Model: LOW VISCOSITY
Model / Ref / Catalog
CPC
Primary DI / UDI-DI
EMICCPC1
Basic UDI-DI
++EMICFAM1ACEM7A
510(k) Number
FDA product code
EBF
EMDN code
Q0101010299 Temporary and permanent dental restoration cements - other
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 — 7 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Dental composite resin

Cleared under the same submission (K062355)

and 8 more cleared under K062355

Similar devices in this category

Other devices filed under TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)