FDA 510(k)

DuoCem

K-Number: K160800 · 2016-11-16

Decision Date2016-11-16

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DuoCem is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K160800. 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 DuoCem?

DuoCem is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K160800.

When did DuoCem receive FDA 510(k) clearance?

DuoCem received FDA 510(k) clearance on 2016-11-16, under 510(k) number K160800.

Who is the listed applicant for DuoCem?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuoCem?

The FDA product code for DuoCem is EMA.

Other records listing Coltene/Whaledent AG 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.

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K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH K254063iCEM Universal PlusKulzer, LLC K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.

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.