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ReminGel

by Inter-Med, Inc. 510(k)

Active United States

510(k) K241489

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241489 Date8 Jan 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LBH
Device Class
Class II
Regulation
21 CFR Part 872.3260
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ReminGel is a cavity varnish classified as a dental device. It is intended for use in dental applications as a protective coating for tooth structures.

This device is manufactured by Inter-Med, Inc. and has received FDA 510(k) clearance. It is categorized as a Class 2 medical device under regulation number 872.3260.

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