Cleared Traditional

e-SDF

K240619 · Kids-E-Dental Llp · Dental

Mar 2024

Decision

Days

Class 2

Risk

About This 510(k) Submission

K240619 is an FDA 510(k) clearance for the e-SDF, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Kids-E-Dental Llp (Mumbai, IN). The FDA issued a Cleared decision on March 6, 2024, 1 days after receiving the submission on March 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K240619 FDA.gov
FDA Decision	Cleared 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

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.