Rennou Varnish (4 models)— 510(k) K243777

Name: FDA 510(k) clearance K243777
Creator: U.S. Food and Drug Administration
Published: 2025-05-27

Substantially Equivalent

Theodent, LLC

FDA 510(k) clearance K243777 for Rennou Varnish (4 models), Substantially Equivalent on 2025-05-27. Applicant: Theodent, LLC. Device class: 2.

Clearance details

Device name as filed: Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
Applicant: Theodent, LLC
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2024-12-09
Decision date: 2025-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Orleans, LA, US

Data sourced from openFDA. This site is unofficial and independent of the FDA.