Cleared Traditional

K241041 - Silver Fluoride Hypersensitivity Varnish (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K241041 is an FDA 510(k) clearance for the Silver Fluoride Hypersensitivity Varnish. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on February 28, 2025 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Young Dental Manufacturing Co. 1, LLC devices

Submission Details

510(k) Number K241041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 127d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

All 7
Devices cleared under the same product code (PHR) and FDA review panel - the closest regulatory comparables to K241041.
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