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Ena Cem

by Micerium S.p.A.

510(k) K062355Ref CPCKModel Cement with bonding

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) K072978

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM1ACEMKL8 Basic UDI-DI EMICCPCK1UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICCPCK1 UDI-DI Date2 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072978 Date17 Jan 2008DecidedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK062355 Date27 Dec 2006ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM1ACEMKL8 registered 12 May 2026 Active
  • FDA 510(k) K072978 decided 17 Jan 2008 Active· +1 more in the status table
  • FDA GUDID UDI-DI EMICCPCK1 listed 2 Dec 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K062355
  2. Cleared FDA 510(k) K072978
  3. Listed FDA GUDID EMICCPCK1
  4. Registered EUDAMED ++EMICFAM1ACEMKL8

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  • Withdrawn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 · 510(k) · GUDID

Trade name
Ena Cem EUDAMED
EnaCem HF GUDID
Generic name
Glass ionomer dental cement
Device name
Ena Cem Procedural
Model / Ref / Catalog
CPCK, Cement with bonding
Primary DI / UDI-DI
EMICCPCK1
Basic UDI-DI
++EMICFAM1ACEMKL8
510(k) Number
FDA product code
EMA, DYH
EMDN code
Q01010104 Dental bonding agents
GMDN term
Glass ionomer dental cement
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 872.3275 510(k)GUDID
872.3750 GUDID
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Advisory committee
Dental
Medical purpose
Luting composite,for cementation of posts and core build-ups, for luting of ceramic and composite inlays, onlays veneers and crowns.
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIa
510(k)
Class II
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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Ena Cem is a dental cement classified as a Dental Cement (OpenFDA: K062355), designed for restorative applications in dentistry. It is formulated as a hybrid restorative composite, combining properties of both cement and composite materials to provide durable and aesthetic dental restorations.

This device is supplied as a dual-cure system, intended for use in clinical settings by dental professionals. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization. The product is non-sterile and supplied in multiple reference codes for various dental applications, with specific attention to compatibility with composite bases and restorative techniques.

Devices cleared under K062355

24 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K062355
UDI-DISize and differences
ENA CEM HF CPC
MICERIUM SPA
CPC / CPCEMICCPC1
Weight 7 g
On the market
ENA CEM HF CPC
MICERIUM SPA
CPC / CPCEMICCPC0
Weight 7 g
On the market
ENA CEM HF CPC-3
MICERIUM SPA
CPC-3 / CPC-3EMICCPC31
Weight 7 g
On the market
ENA CEM HF CPC-3
MICERIUM SPA
CPC-3 / CPC-3EMICCPC30
Weight 7 g
On the market
ENA CEM HF CPC-3UD2
MICERIUM SPA
CPC-3UD2 / CPC-3UD2EMICCPC3UD20
Weight 7 g
On the market
ENA CEM HF CPC-3UD2
MICERIUM SPA
CPC-3UD2 / CPC-3UD2EMICCPC3UD21
Weight 7 g
On the market
ENA CEM HF CPCTK
MICERIUM SPA
CPCTK / CPCTKEMICCPCTK1
Weight 7 g
On the market
ENA CEM HF CPCTUD0
MICERIUM SPA
CPCTUD0 / CPCTUD0EMICCPCTUD00
Weight 7 g
On the market
ENA CEM HF CPCTUD1
MICERIUM SPA
CPCTUD1 / CPCTUD1EMICCPCTUD10
Weight 7 g
On the market
ENA CEM HF CPCTUD2
MICERIUM SPA
CPCTUD2 / CPCTUD2EMICCPCTUD20
Weight 7 g
On the market
ENA CEM HF CPCTUD3
MICERIUM SPA
CPCTUD3 / CPCTUD3EMICCPCTUD30
Weight 7 g
On the market
ENA CEM HF CPCTUD4
MICERIUM SPA
CPCTUD4 / CPCTUD4EMICCPCTUD40
Weight 7 g
On the market
ENA CEM HF CPCUD1
MICERIUM SPA
CPCUD1 / CPCUD1EMICCPCUD11
Weight 7 g
On the market
ENA CEM HF CPCUD1
MICERIUM SPA
CPCUD1 / CPCUD1EMICCPCUD10
Weight 7 g
On the market
ENA CEM HF CPCUD2
MICERIUM SPA
CPCUD2 / CPCUD2EMICCPCUD21
Weight 7 g
On the market
ENA CEM HF CPCUD2
MICERIUM SPA
CPCUD2 / CPCUD2EMICCPCUD20
Weight 7 g
On the market
ENA CEM HF CPCUD3
MICERIUM SPA
CPCUD3 / CPCUD3EMICCPCUD30
Weight 7 g
On the market
ENA CEM HF CPCUD3
MICERIUM SPA
CPCUD3 / CPCUD3EMICCPCUD31
Weight 7 g
On the market
ENA CEM HF CPCUD4
MICERIUM SPA
CPCUD4 / CPCUD4EMICCPCUD40
Weight 7 g
On the market
ENA CEM HF CPCUD4
MICERIUM SPA
CPCUD4 / CPCUD4EMICCPCUD41
Weight 7 g
On the market
ENA CEM HF CPCZ
MICERIUM SPA
CPCZ / CPCZEMICCPCZ1
Weight 7 g
On the market
ENA CEM HF CPCZ
MICERIUM SPA
CPCZ / CPCZEMICCPCZ0
Weight 7 g
On the market
EnaCem HF CPCK
MICERIUM SPA
CPCK / CPCKEMICCPCK1 —On the market
EnaCem Z CPCZK
MICERIUM SPA
CPCZK / CPCZKEMICCPCZK1
Weight 8 g; Total Volume 5 mL
On the market

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

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Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)