510(k) K261134

Dormiva Anti-Snoring Mouth Guard by Koncept Innovators, Inc. — Product Code LRK

K261134 is an FDA 510(k) premarket notification submitted by Koncept Innovators, Inc. for the device "Dormiva Anti-Snoring Mouth Guard". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Koncept Innovators, Inc. has at least 2 other 510(k) clearances on record.