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FDA 510(k)

Silver Fluoride Hypersensitivity Varnish

K-Number: K241041 · 2025-02-28

Decision Date2025-02-28
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Silver Fluoride Hypersensitivity Varnish is a medical device manufactured by Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2025-02-28 under approval 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. It is manufactured by Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K241041.

When was Silver Fluoride Hypersensitivity Varnish approved by the FDA?

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

What company makes Silver Fluoride Hypersensitivity Varnish?

Silver Fluoride Hypersensitivity Varnish is manufactured by Young Dental Manufacturing Co. 1, LLC.

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

The FDA product code for Silver Fluoride Hypersensitivity Varnish is PHR.

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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.