Cleared Traditional

ProMin Dental Desensitizing Gel

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

About This 510(k) Submission

K231060 is an FDA 510(k) clearance for the ProMin Dental Desensitizing Gel, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on June 13, 2024, 427 days after receiving the submission on April 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K231060 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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