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FDA 510(k)

VarseoSmile Crown plus

K-Number: K201668 · 2020-06-23

Decision Date2020-06-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VarseoSmile Crown plus is a medical device manufactured by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2020-06-23 under approval number K201668. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VarseoSmile Crown plus?

VarseoSmile Crown plus is a medical device that received FDA 510(k) clearance on 2020-06-23. It is manufactured by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K201668.

When was VarseoSmile Crown plus approved by the FDA?

VarseoSmile Crown plus received FDA 510(k) clearance on 2020-06-23, under approval number K201668.

What company makes VarseoSmile Crown plus?

VarseoSmile Crown plus is manufactured by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG.

What is the FDA product code for VarseoSmile Crown plus?

The FDA product code for VarseoSmile Crown plus is EBF.

Other Devices by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG

Related Devices (Code: EBF)

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.