LRK — Device, Anti-Snoring Class II
FDA Device Classification
Classification Details
- Product Code
- LRK
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253845 | ram.shaw pte. | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | March 3, 2026 |
| K252531 | myofunctional research | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | March 2, 2026 |
| K252976 | park dental research | Park Dental Nylon MAD | December 18, 2025 |
| K253868 | quietlab | QuietLab Pro | December 5, 2025 |
| K252161 | good sleep co pte | Hushd Avera | November 25, 2025 |
| K252525 | aiomega | AIO Breathe | November 6, 2025 |
| K252698 | nightguard express | NightGuard Aire Max | November 3, 2025 |
| K253355 | fissiontech | Difiney Advanced Anti Snoring Device 4.0 | October 29, 2025 |
| K251784 | good sleep co pte | Hushd Pro Z-Link | October 24, 2025 |
| K251628 | dcstar | Mandibular Advancement Device L07 | October 22, 2025 |
| K250028 | dongguan yiyao science and technology development co | Anti Snore Mouthpiece | October 3, 2025 |
| K243752 | tmj clinic pc | Double Tube Herbst Appliance | September 17, 2025 |
| K252374 | airway technologies d/b/a airway management | Nylon flexTAP(R) | September 11, 2025 |
| K250353 | oniris | Oniris; Oniris Plus | September 4, 2025 |
| K250122 | splintek | SleepRight Snore Aid | May 19, 2025 |
| K250482 | fissiontech | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | May 8, 2025 |
| K234089 | vivos therapeutics | DNA Appliance | September 16, 2024 |
| K232025 | good sleep co pte | Hushd Pro Avera | May 9, 2024 |
| K232735 | ema sleep incorporated | EMA 3D | May 3, 2024 |
| K233850 | fissiontech | Difiney Anti Snoring Device | April 18, 2024 |