Cleared Traditional

K240619 - e-SDF (FDA 510(k) Clearance)

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

K240619 · Kids-E-Dental Llp · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
1d
Days
Class 2
Risk

K240619 is an FDA 510(k) clearance for the e-SDF. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Kids-E-Dental Llp (Mumbai, IN). The FDA issued a Cleared decision on March 6, 2024 after a review of 1 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kids-E-Dental Llp devices

Submission Details

510(k) Number K240619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2024
Decision Date March 06, 2024
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K240619.
SDF Pro
K250222 · Belport Company, Inc., Gingi-Pak · May 2025
Silver Fluoride Hypersensitivity Varnish
K241041 · Young Dental Manufacturing Co. 1, LLC · Feb 2025
FAgamin®
K240059 · Tedequim Srl · May 2024
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · Centrix, Inc. · Oct 2023
Black Diamond
K222323 · Elevate Oral Care, LLC · Jun 2023