Centrix FluoroSilver Silver Diamine Fluoride 38%
K-Number: K222459 · 2023-10-27
ApplicantCentrix, Inc.
Decision Date2023-10-27
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Centrix FluoroSilver Silver Diamine Fluoride 38% is a medical device manufactured by Centrix, Inc.. It received FDA 510(k) clearance on 2023-10-27 under approval number K222459. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Centrix FluoroSilver Silver Diamine Fluoride 38%?
Centrix FluoroSilver Silver Diamine Fluoride 38% is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Centrix, Inc.. The 510(k) number is K222459.
When was Centrix FluoroSilver Silver Diamine Fluoride 38% approved by the FDA?
Centrix FluoroSilver Silver Diamine Fluoride 38% received FDA 510(k) clearance on 2023-10-27, under approval number K222459.
What company makes Centrix FluoroSilver Silver Diamine Fluoride 38%?
Centrix FluoroSilver Silver Diamine Fluoride 38% is manufactured by Centrix, Inc..
What is the FDA product code for Centrix FluoroSilver Silver Diamine Fluoride 38%?
The FDA product code for Centrix FluoroSilver Silver Diamine Fluoride 38% is PHR.
Other Devices by Centrix, Inc.
Related Devices (Code: PHR)
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.