Cleared Traditional

SDF Pro

K250222 · Belport Company, Inc., Gingi-Pak · Dental
May 2025
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K250222 is an FDA 510(k) clearance for the SDF Pro, a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II — Special Controls, product code PHR), submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on May 7, 2025, 100 days after receiving the submission on January 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K250222 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date May 07, 2025
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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.