Cleared Traditional

K250222 - SDF Pro (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K250222 is an FDA 510(k) clearance for the SDF Pro. Classified as Diammine Silver Fluoride Dental Hypersensitivity Varnish (product code PHR), Class II - Special Controls.

Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on May 7, 2025 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Belport Company, Inc., Gingi-Pak devices

Submission Details

510(k) Number K250222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
Definition Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

All 7
Devices cleared under the same product code (PHR) and FDA review panel - the closest regulatory comparables to K250222.
Silver Fluoride Hypersensitivity Varnish
K241041 · Young Dental Manufacturing Co. 1, LLC · Feb 2025
FAgamin®
K240059 · Tedequim Srl · May 2024
e-SDF
K240619 · Kids-E-Dental Llp · Mar 2024
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · Centrix, Inc. · Oct 2023
Black Diamond
K222323 · Elevate Oral Care, LLC · Jun 2023