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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) 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. The listed applicant is Centrix, Inc.. The 510(k) number is K222459.

When did Centrix FluoroSilver Silver Diamine Fluoride 38% receive FDA 510(k) clearance?

Centrix FluoroSilver Silver Diamine Fluoride 38% received FDA 510(k) clearance on 2023-10-27, under 510(k) number K222459.

Who is the listed applicant for Centrix FluoroSilver Silver Diamine Fluoride 38%?

The FDA 510(k) record lists Centrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05395065Silver Diamine Fluoride Gel: Single Group Observational StudyCOMPLETED

Other records listing Centrix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250714FluoroDose VarnishK200764STATSTIXK152826NoCord

Related Devices (Code: PHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250222SDF ProBelport Company, Inc., Gingi-PakK241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLCK240059FAgamin®Tedequim SrlK240619e-SDFKids-E-Dental LlpK222323Black DiamondElevate Oral Care, LLCK172047Riva StarSdi Limited

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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