Cleared Traditional

ProMin Dental Desensitizing Gel (K231060) - FDA 510(k) Clearance

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

K231060 · Belport Company, Inc., Gingi-Pak · Dental device
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Jun 2024
Decision
427d
Days
Class 2
Risk

K231060 is an FDA 510(k) clearance for the ProMin Dental Desensitizing Gel. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on June 13, 2024 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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

Submission Details

510(k) Number K231060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2023
Decision Date June 13, 2024
Days to Decision 427 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
300d slower than avg
Panel avg: 127d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 32
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K231060.
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · GreenMark Biomedical, Inc. · Jan 2025
Jasmate® Toothpaste
K242913 · Jasberry Healthcare Private Limited · Nov 2024
Papacarie Duo
K233768 · Elevate Oral Care · Jul 2024
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
K230333 · Kettenbach GmbH & Co. KG · Jul 2023
Dental Desensitizer
K222891 · Guangzhou Beogene Biotech Co., Ltd. · May 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · 3M Espe Dental Products · May 2023