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FDA 510(k)

DuoCem

K-Number: K160800 · 2016-11-16

ApplicantColtene/Whaledent AG
Decision Date2016-11-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DuoCem is a medical device manufactured by Coltene/Whaledent AG. It received FDA 510(k) clearance on 2016-11-16 under approval 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. It is manufactured by Coltene/Whaledent AG. The 510(k) number is K160800.

When was DuoCem approved by the FDA?

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

What company makes DuoCem?

DuoCem is manufactured by Coltene/Whaledent AG.

What is the FDA product code for DuoCem?

The FDA product code for DuoCem is EMA.

Other Devices by Coltene/Whaledent AG

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Official Source

View on FDA Database →

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

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