510(k) K243752

Double Tube Herbst Appliance by The Tmj Clinic PC — Product Code LRK

K243752 is an FDA 510(k) premarket notification submitted by The Tmj Clinic PC for the device "Double Tube Herbst Appliance". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. The Tmj Clinic PC has at least 1 other 510(k) clearance on record.