Cleared Traditional

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

K243777 · Theodent, LLC · Dental
May 2025
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K243777 is an FDA 510(k) clearance for the Rennou? Varnish (3% / Spearmint); Rennou? Varnish (3% / Strawberry); Rennou? Varnish (3% / Cherry); Rennou? Varnish (3% / Bubble Gum), a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Theodent, LLC (New Orleans, US). The FDA issued a Cleared decision on May 27, 2025, 169 days after receiving the submission on December 9, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K243777 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2024
Decision Date May 27, 2025
Days to Decision 169 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