Cleared Traditional

Centrix FluoroSilver Silver Diamine Fluoride 38%

K222459 · Centrix, Inc. · Dental
Oct 2023
Decision
438d
Days
Class 2
Risk

About This 510(k) Submission

K222459 is an FDA 510(k) clearance for the Centrix FluoroSilver Silver Diamine Fluoride 38%, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 27, 2023, 438 days after receiving the submission on August 15, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K222459 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2022
Decision Date October 27, 2023
Days to Decision 438 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.