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Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)

by Theodent, LLC

510(k) K243777

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243777 Date27 May 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 23 Sep 2026

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

Rennou Varnish is a cavity varnish intended for use in dental applications. It functions as a protective coating for the teeth.

This device is regulated under FDA 510(k) clearance as a Class 2 dental varnish. It is available in multiple flavor variants, including Spearmint, Strawberry, Cherry, and Bubble Gum.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary purpose of Rennou Varnish?

    Rennou Varnish is intended for use in dental applications as a protective coating for the teeth to assist in cavity management.

  • What flavor options are available for this device?

    The varnish is available in four flavor variants: Spearmint, Strawberry, Cherry, and Bubble Gum.

  • How is this device regulated?

    Rennou Varnish is regulated under FDA 510(k) clearance as a Class 2 dental varnish, identified by the product code LBH and regulation number 872.3260.