e-SDF

FDA 510(k) K240619 · Kids-E-Dental Llp

Substantially Equivalent

510(k) numberK240619

Submission

Device name
e-SDF
Applicant
Kids-E-Dental Llp
Mumbai, IN
Received
March 5, 2024
Decision date
March 6, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
PHR – Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3260
Specialty
Dental

Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.

Other 510(k)s with product code PHR

510(k)DeviceApplicantDecision
K250222SDF ProPHR · Traditional Belport Company, Inc., Gingi-Pak05/07/2025SE
K241041Silver Fluoride Hypersensitivity VarnishPHR · Traditional Young Dental Manufacturing Co. 1, LLC02/28/2025SE
K240059FAgamin®PHR · Traditional Tedequim Srl05/16/2024SE
K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHR · Traditional Centrix, Inc.10/27/2023SE
K222323Black DiamondPHR · Traditional Elevate Oral Care, LLC06/23/2023SE
K172047Riva StarPHR · Traditional Sdi Limited04/11/2018SE
K102973Silver Dental ArrestPHR · Traditional Cooley Consulting, Inc.07/31/2014SE

Questions and answers

When was e-SDF cleared by the FDA?

e-SDF (K240619) received a 510(k) decision of Substantially Equivalent on March 6, 2024, 1 days after the submission was received.

What is the product code of K240619?

The FDA product code is PHR – Diammine Silver Fluoride Dental Hypersensitivity Varnish, a Class II (moderate risk) device regulated under 21 CFR 872.3260.