LRK
- Product code
- LRK
- Device name
- Device, Anti-Snoring
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.5570
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 31
- Summaries archived here
- 27 (direct download)
- 510(k) clearances (all years, FDA)
- 215 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (31)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262104 | 2026-08-27 | Ram.Shaw Pte., Ltd. | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09… | |
| K261912 | 2026-07-31 | DnB Innovations, LLC | SnØreNegatØr | |
| K261366 | 2026-06-12 | Somnomed, Inc. | Virtus | FDA |
| K261251 | 2026-06-11 | Endeavor Commerce, LLC | Snorbliss® Anti-Snoring Device | |
| K261134 | 2026-05-14 | Koncept Innovators, Inc. | Dormiva Anti-Snoring Mouth Guard | |
| K252942 | 2026-04-10 | Shaeferh, LLC | ShaeferH | |
| K253845 | 2026-03-03 | Ram.Shaw Pte. , Ltd. | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08… | |
| K252531 | 2026-03-02 | Myofunctional Research Co. | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers… | |
| K252976 | 2025-12-18 | Park Dental Research Corp. | Park Dental Nylon MAD | |
| K253868 | 2025-12-05 | QuietLab, LLC | QuietLab Pro | |
| K252161 | 2025-11-25 | Good Sleep CO Pte , Ltd. | Hushd Avera | |
| K252525 | 2025-11-06 | Aiomega, LLC | AIO Breathe | FDA |
| K252698 | 2025-11-03 | Nightguard Express, LLC | NightGuard Aire Max | |
| K253355 | 2025-10-29 | Fissiontech, LLC | Difiney Advanced Anti Snoring Device 4.0 | |
| K251784 | 2025-10-24 | Good Sleep CO Pte , Ltd. | Hushd Pro Z-Link | |
| K251628 | 2025-10-22 | Dcstar, Inc. | Mandibular Advancement Device L07 | |
| K250028 | 2025-10-03 | Dongguan Yiyao Science & Technology De… | Anti Snore Mouthpiece | |
| K243752 | 2025-09-17 | The Tmj Clinic PC | Double Tube Herbst Appliance | |
| K252374 | 2025-09-11 | Airway Technologies D/B/A Airway Manag… | Nylon flexTAP(R) | |
| K250353 | 2025-09-04 | Oniris | Oniris; Oniris Plus | |
| K250122 | 2025-05-19 | Splintek, Inc. | SleepRight Snore Aid | |
| K250482 | 2025-05-08 | Fissiontech, LLC | Advanced Anti Snoring Device 4.0 Clear/ Advanced Ant… | |
| K234089 | 2024-09-16 | Vivos Therapeutics | DNA Appliance | |
| K232025 | 2024-05-09 | Good Sleep CO Pte , Ltd. | Hushd Pro Avera | |
| K232735 | 2024-05-03 | Ema Sleep Incorporated | EMA 3D | |
| K233850 | 2024-04-18 | Fissiontech, LLC | Difiney Anti Snoring Device | |
| K240427 | 2024-02-14 | Gelb Practice Solutions, Inc. | airVata | |
| K231138 | 2024-01-16 | Oscimed SA | Aniti-Snore Mouthguard+ | |
| K230947 | 2023-11-28 | Vivos Therapeutics, Inc. | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | FDA |
| K233434 | 2023-11-14 | Prismatik Dentalcraft, Inc. | Silent Nite® Sleep Appliance with the Glidewell Hing… | |
| K231663 | 2023-09-18 | Innovative Health Technologies (Nz), L… | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | — |
Official FDA classification page: LRK
Classification and pathway per current FDA publications. Data from openFDA (CC0).