Home / Device Classification / PHR

PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish Class II

FDA Device Classification

Classification Details

Product Code
PHR
Device Class
Class II
Regulation Number
872.3260
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250222belport company, inc., gingi-pakSDF ProMay 7, 2025
K241041young dental manufacturing co. 1Silver Fluoride Hypersensitivity VarnishFebruary 28, 2025
K240059tedequimFAgamin®May 16, 2024
K240619kids-e-dentale-SDFMarch 6, 2024
K222459centrixCentrix FluoroSilver Silver Diamine Fluoride 38%October 27, 2023
K222323elevate oral careBlack DiamondJune 23, 2023
K172047sdi limitedRiva StarApril 11, 2018
K102973cooley consultingSILVER DENTAL ARRESTJuly 31, 2014