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Ena Cem Hf Cpc-3

by Micerium SpA

Ena Cem Hf Cpc-3 is a Class II device made by Micerium SpA, cleared under FDA 510(k) K062355 on 27 Dec 2006 and listed in FDA GUDID since 3 Apr 2025 (UDI-DI EMICCPC30), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K062355

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEMICCPC30 UDI-DI Date3 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062355 Date27 Dec 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062355 decided 27 Dec 2006 Active
  • FDA GUDID UDI-DI EMICCPC30 listed 3 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062355
  2. Listed FDA GUDID EMICCPC30

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ena Cem Hf
Generic name
Dental composite resin
Model / Ref / Catalog
CPC-3
Primary DI / UDI-DI
EMICCPC30
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution
Size
Weight — 7 Gram

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 Dental composite resin.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

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