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.
FDA 510(k) Cleared Diammine Silver Fluoride Dental Hypersensitivity Varnish Devices (Product Code PHR)
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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under PHR have taken an average of 182 days to reach a decision - down from 487 days historically, suggesting improved FDA processing for this classification.
PHR devices are reviewed by the Dental panel. Browse all Dental devices →