K243752 is an FDA 510(k) clearance for the Double Tube Herbst Appliance. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by The Tmj Clinic PC (Portland, US). The FDA issued a Cleared decision on September 17, 2025, 286 days after receiving the submission on December 5, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K243752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2024 |
| Decision Date | September 17, 2025 |
| Days to Decision | 286 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |