Product code LRK
- Device name
- Device, Anti-Snoring
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5570
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026-07-31 |
| K261366 | Virtus | Somnomed, Inc. | 2026-06-12 |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | 2026-06-11 |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | 2026-05-14 |
| K252942 | ShaeferH | Shaeferh, LLC | 2026-04-10 |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | 2026-03-03 |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026-03-02 |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 |
| K253868 | QuietLab Pro | QuietLab, LLC | 2025-12-05 |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 2025-11-25 |
| K252525 | AIO Breathe | Aiomega, LLC | 2025-11-06 |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025-11-03 |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | 2025-10-29 |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | 2025-10-24 |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025-10-22 |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | 2025-09-17 |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | 2025-09-11 |
| K250353 | Oniris; Oniris Plus | Oniris | 2025-09-04 |
| K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025-05-19 |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | 2025-05-08 |
| K234089 | DNA Appliance | Vivos Therapeutics | 2024-09-16 |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | 2024-05-09 |
| K232735 | EMA 3D | Ema Sleep Incorporated | 2024-05-03 |
| K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024-04-18 |
| K240427 | airVata™ | Gelb Practice Solutions, Inc. | 2024-02-14 |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | 2024-01-16 |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023-11-28 |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | Prismatik Dentalcraft, Inc. | 2023-11-14 |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. | 2023-09-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850077473173 | Individual EMA Straps(EMAST17Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473319 | Individual EMA Straps(EMAST13C) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473302 | Individual EMA Straps(EMAST21B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473296 | Individual EMA Straps(EMAST20B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473289 | Individual EMA Straps(EMAST19B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473272 | Individual EMA Straps(EMAST18B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473265 | Individual EMA Straps(EMAST17B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473258 | Individual EMA Straps(EMAST16B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473241 | Individual EMA Straps(EMAST15B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473234 | Individual EMA Straps(EMAST14B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473227 | Individual EMA Straps(EMAST13B) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473210 | Individual EMA Straps(EMAST21Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473203 | Individual EMA Straps(EMAST20Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473197 | Individual EMA Straps(EMAST19Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473180 | Individual EMA Straps(EMAST18Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473005 | EMA NOW PATIENT STARTER KITS | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473166 | Individual EMA Straps(EMAST16Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473159 | Individual EMA Straps(EMAST15Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473142 | Individual EMA Straps(EMAST14Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473135 | Individual EMA Straps(EMAST13Y) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473128 | Individual EMA Straps(EMAST21W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473111 | Individual EMA Straps(EMAST20W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473104 | Individual EMA Straps(EMAST19W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473098 | Individual EMA Straps(EMAST18W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473081 | Individual EMA Straps(EMAST17W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473074 | Individual EMA Straps(EMAST16W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473067 | Individual EMA Straps(EMAST15W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473050 | Individual EMA Straps(EMAST14W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473043 | INDIVIDUAL EMA STRAPS(EMAST13W) | EMA SLEEP INCORPORATED | 2026-08-14 |
| 00850077473012 | EMA Serena Patient Starter kits | EMA SLEEP INCORPORATED | 2026-08-14 |