PHR

Diammine Silver Fluoride Dental Hypersensitivity Varnish

Product code
PHR
Device name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device class
Class 2
21 CFR
21 CFR 872.3260
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
5
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
8 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-05-07.

NumberDecision dateApplicantDevice nameSummary
K2502222025-05-07Belport Company, Inc., Gingi-PakSDF Pro
K2410412025-02-28Young Dental Manufacturing Co. 1, LLCSilver Fluoride Hypersensitivity VarnishPDF
K2400592024-05-16Tedequim SrlFAgamin®PDF
K2406192024-03-06Kids-E-Dental Llpe-SDFFDA
K2224592023-10-27Centrix, Inc.Centrix FluoroSilver Silver Diamine Fluoride 38%PDF

3 summaries are archived here for direct download.

Official FDA classification page: PHR
Classification and pathway per current FDA publications. Data from openFDA (CC0).