Cleared Traditional

ReminGel

K241489 · Inter-Med, Inc. · Dental
Jan 2025
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K241489 is an FDA 510(k) clearance for the ReminGel, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on January 8, 2025, 229 days after receiving the submission on May 24, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K241489 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2024
Decision Date January 08, 2025
Days to Decision 229 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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