FDA 510(k)

Silver Fluoride Hypersensitivity Varnish

K-Number: K241041 · 2025-02-28

ApplicantYoung Dental Manufacturing Co. 1, LLC

Decision Date2025-02-28

Product CodePHR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Silver Fluoride Hypersensitivity Varnish is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241041. 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 Silver Fluoride Hypersensitivity Varnish?

Silver Fluoride Hypersensitivity Varnish is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K241041.

When did Silver Fluoride Hypersensitivity Varnish receive FDA 510(k) clearance?

Silver Fluoride Hypersensitivity Varnish received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241041.

Who is the listed applicant for Silver Fluoride Hypersensitivity Varnish?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silver Fluoride Hypersensitivity Varnish?

The FDA product code for Silver Fluoride Hypersensitivity Varnish 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 NCT07286344Effect of Fluoride Varnish Formulation on the Management of Dentin HypersensitivityRECRUITING NCT07622043Effectiveness of Two Different Desensitizing Dental VarnishesNOT_YET_RECRUITING

Other records listing Young Dental Manufacturing Co. 1, LLC as applicant

K201127DEFEND Ear-loop Face Masks K171377Young INFINITY Cordless Handpiece System K153334Oral-B 5% Sodium Fluoride Varnish

Related Devices (Code: PHR)

K250222SDF ProBelport Company, Inc., Gingi-Pak K240059FAgamin®Tedequim Srl K240619e-SDFKids-E-Dental Llp K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.K222323Black DiamondElevate Oral Care, LLC K172047Riva StarSdi Limited

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.