Double Tube Herbst Appliance
K-Number: K243752 · 2025-09-17
ApplicantThe Tmj Clinic PC
Decision Date2025-09-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Double Tube Herbst Appliance is a medical device manufactured by The Tmj Clinic PC. It received FDA 510(k) clearance on 2025-09-17 under approval number K243752. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Double Tube Herbst Appliance?
Double Tube Herbst Appliance is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by The Tmj Clinic PC. The 510(k) number is K243752.
When was Double Tube Herbst Appliance approved by the FDA?
Double Tube Herbst Appliance received FDA 510(k) clearance on 2025-09-17, under approval number K243752.
What company makes Double Tube Herbst Appliance?
Double Tube Herbst Appliance is manufactured by The Tmj Clinic PC.
What is the FDA product code for Double Tube Herbst Appliance?
The FDA product code for Double Tube Herbst Appliance is LRK.
Other Devices by The Tmj Clinic PC
Related Devices (Code: LRK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.