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FDA 510(k)

VarseoSmile TriniQ

K-Number: K233596 · 2023-11-09

Decision Date2023-11-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VarseoSmile TriniQ is a medical device manufactured by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2023-11-09 under approval number K233596. 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 TriniQ?

VarseoSmile TriniQ is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K233596.

When was VarseoSmile TriniQ approved by the FDA?

VarseoSmile TriniQ received FDA 510(k) clearance on 2023-11-09, under approval number K233596.

What company makes VarseoSmile TriniQ?

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

What is the FDA product code for VarseoSmile TriniQ?

The FDA product code for VarseoSmile TriniQ 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.