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FDA 510(k)

FluoroDose Varnish

K-Number: K250714 · 2025-11-21

ApplicantCentrix, Inc.
Decision Date2025-11-21
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FluoroDose Varnish is a medical device manufactured by Centrix, Inc.. It received FDA 510(k) clearance on 2025-11-21 under approval number K250714. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FluoroDose Varnish?

FluoroDose Varnish is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Centrix, Inc.. The 510(k) number is K250714.

When was FluoroDose Varnish approved by the FDA?

FluoroDose Varnish received FDA 510(k) clearance on 2025-11-21, under approval number K250714.

What company makes FluoroDose Varnish?

FluoroDose Varnish is manufactured by Centrix, Inc..

What is the FDA product code for FluoroDose Varnish?

The FDA product code for FluoroDose Varnish is LBH.

Other Devices by Centrix, Inc.

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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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