Cleared Traditional

Silver Fluoride Hypersensitivity Varnish

K241041 · Young Dental Manufacturing Co. 1, LLC · Dental
Feb 2025
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K241041 is an FDA 510(k) clearance for the Silver Fluoride Hypersensitivity Varnish, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on February 28, 2025, 318 days after receiving the submission on April 16, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K241041 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2024
Decision Date February 28, 2025
Days to Decision 318 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.