K243777

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

510(k) number: K243777
Device name: Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
Applicant: Theodent, LLC LA · US
Product code: LBH — Varnish, Cavity
Decision date: 2025-05-27
Date received: 2024-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Dental

Also available from FDA: K243777.pdf

Official FDA record: K243777

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.