FDA 510(k)

ENA CEM

K-Number: K062355 · 2006-12-27

Decision Date2006-12-27

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ENA CEM is the device name listed in this FDA 510(k) record. The listed applicant is Micerium S.P.A.. It received FDA 510(k) clearance on 2006-12-27 under 510(k) number K062355. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA CEM?

ENA CEM is a medical device that received FDA 510(k) clearance on 2006-12-27. The listed applicant is Micerium S.P.A.. The 510(k) number is K062355.

When did ENA CEM receive FDA 510(k) clearance?

ENA CEM received FDA 510(k) clearance on 2006-12-27, under 510(k) number K062355.

Who is the listed applicant for ENA CEM?

The FDA 510(k) record lists Micerium S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENA CEM?

The FDA product code for ENA CEM is EMA.

Other records listing Micerium S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103474ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)K072978TENDER ORTHO BOND-ENA BOND-ENA ETCH K063170TENDER FIBER K062367MINISCREWS ANCHORING SYSTEM, M.A.S.K062906ENA HFO COMPOSITE SYSTEM

Related Devices (Code: EMA)

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.