FDA Product Code PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish
Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.
Leading manufacturers include Sdi Limited, Elevate Oral Care, LLC and Centrix, Inc..
8
Total
8
Cleared
373d
Avg days
2014
Since
Declining activity -
2 submissions in the last 2 years
vs 4 in the prior period
Review times improving: avg
209d
recently vs 428d historically
FDA 510(k) Cleared Diammine Silver Fluoride Dental Hypersensitivity Varnish Devices (Product Code PHR)
8 devices
Cleared
May 07, 2025
SDF Pro
Belport Company, Inc., Gingi-Pak
Dental
100d
Cleared
Feb 28, 2025
Silver Fluoride Hypersensitivity Varnish
Young Dental Manufacturing Co. 1, LLC
Dental
318d
Cleared
May 16, 2024
FAgamin®
Tedequim Srl
Dental
129d
Cleared
Mar 06, 2024
e-SDF
Kids-E-Dental Llp
Dental
1d
Cleared
Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
Centrix, Inc.
Dental
438d
Cleared
Jun 23, 2023
Black Diamond
Elevate Oral Care, LLC
Dental
325d
Cleared
Apr 11, 2018
Riva Star
Sdi Limited
Dental
279d
About Product Code PHR - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PHR since 2014, with 8 receiving FDA clearance (average review time: 373 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - PHR Product Code
Recent submissions under PHR have taken an average of 209 days to reach a decision - down from 428 days historically, suggesting improved FDA processing for this classification.
PHR devices are reviewed by the Dental panel. Browse all Dental devices →