PHR · Class II · 21 CFR 872.3260

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 Tedequim Srl, Kids-E-Dental Llp and Young Dental Manufacturing Co. 1, LLC.

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
1–8 of 8
Cleared May 07, 2025
SDF Pro
K250222
Belport Company, Inc., Gingi-Pak
Dental · 100d
Cleared Feb 28, 2025
Silver Fluoride Hypersensitivity Varnish
K241041
Young Dental Manufacturing Co. 1, LLC
Dental · 318d
Cleared May 16, 2024
FAgamin®
K240059
Tedequim Srl
Dental · 129d
Cleared Mar 06, 2024
e-SDF
K240619
Kids-E-Dental Llp
Dental · 1d
Cleared Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459
Centrix, Inc.
Dental · 438d
Cleared Jun 23, 2023
Black Diamond
K222323
Elevate Oral Care, LLC
Dental · 325d
Cleared Apr 11, 2018
Riva Star
K172047
Sdi Limited
Dental · 279d
Cleared Jul 31, 2014
SILVER DENTAL ARREST
K102973
Cooley Consulting, Inc.
Dental · 1394d

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 →