510(k) K243777

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) by Theodent, LLC — Product Code LBH

K243777 is an FDA 510(k) premarket notification submitted by Theodent, LLC for the device "Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)". The FDA issued a decision of Substantially Equivalent on May 27, 2025. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260.