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FDA 510(k)

Nano Varnish, Plaquit, Lightpaint on Surface

K-Number: K162408 · 2018-04-05

ApplicantDreve Dentamid GmbH
Decision Date2018-04-05
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nano Varnish, Plaquit, Lightpaint on Surface is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-05 under approval number K162408. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano Varnish, Plaquit, Lightpaint on Surface?

Nano Varnish, Plaquit, Lightpaint on Surface is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K162408.

When was Nano Varnish, Plaquit, Lightpaint on Surface approved by the FDA?

Nano Varnish, Plaquit, Lightpaint on Surface received FDA 510(k) clearance on 2018-04-05, under approval number K162408.

What company makes Nano Varnish, Plaquit, Lightpaint on Surface?

Nano Varnish, Plaquit, Lightpaint on Surface is manufactured by Dreve Dentamid GmbH.

What is the FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface?

The FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface is EBD.

Other Devices by Dreve Dentamid GmbH

K171729Fixtemp C&B K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono K190571StoneBite and StoneBite scan K200580FotoDent denture K250739Primeprint Direct Aligner

Related Devices (Code: EBD)

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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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