Dental Device Guide
Add your company

Prosthetic devices · 21 CFR 872 Subpart D

Diammine Silver Fluoride Dental Hypersensitivity Varnish

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

FDA codePHRClass221 CFR872.3260Pathway510(k)
Companies listing it
108 makers
Brands and models
12
510(k) clearances
86 in five years
FDA name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
2014: 12018: 12023: 22024: 22025: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list PHR

10 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Young Innovations IncUnited StatesMakerClearDefense Silver Fluoride Hypersensitivity Varnish232025
Sdi LimitedAustraliaMakerRiva Star82022
Centrix, Inc.United StatesMakerSilverSense SDF442025
Elevate Oral CareUnited StatesMakerAdvantage Arrest · Advantage Arrest Gel · Advantage Arrest Silver Diamine Fluoride 38% and FluoriMax 2.5% Sodium Fluoride Varnish Convenience Kit · Advantage Arrest Unit Dose32024
Kids-E-Dental LLPIndiaMakere-SDF12024
HEXA DentalUnited StatesMaker———
Organic Consultants, LLCUnited StatesMakerSILVER DENTAL ARREST——
Baron Analytical Laboratories LLCUnited StatesMaker———
NuSmile, Ltd.United StatesManufacturerAvalon Biomed Silver Diamine Fluoride (SDF) · NuSmile NuNamel Silver Diamine Fluoride (SDF) · NuSmile Silver Diamine Fluoride (SDF)22026
medmix Deutschland GmbHGermanyContract manufacturer———

510(k) clearances

Decided510(k)DeviceApplicant
7 May 2025K250222SDF ProBelport Company, Inc., Gingi-Pak
28 Feb 2025K241041Silver Fluoride Hypersensitivity VarnishYoung Innovations Inc
16 May 2024K240059FAgamin®Tedequim Srl
6 Mar 2024K240619e-SDFKids-E-Dental LLP
27 Oct 2023K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.
23 Jun 2023K222323Black DiamondElevate Oral Care
11 Apr 2018K172047Riva StarSdi Limited
31 Jul 2014K102973SILVER DENTAL ARRESTCooley Consulting, Inc.

Official records: FDA product classification for PHR · 21 CFR 872.3260.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026