Device, Anti-Snoring
Regulation 872.5570
14510(k)s in 12 months (217 all time)
2recalls in 12 months (10 all time)
6recalls that name a 510(k)
Top companies in LRK
| Company | 510(k)s | Recalls |
|---|---|---|
| Somnomed, Inc. | 9 | 0 |
| Respire Medical | 3 | 5 |
| Sleeping Well, LLC | 6 | 0 |
| Prismatik Dentalcraft, Inc. | 4 | 1 |
| Airway Management, Inc. | 4 | 0 |
| Allen J. Moses, Dds, Ltd. | 4 | 0 |
| Always More Marketing | 4 | 0 |
| Medtronic Xomed, Inc. | 2 | 2 |
| Oventus Manufacturing Pty, Ltd. | 4 | 0 |
| Dental Imagineers, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | K262937 | PDR Airway Device Park Dental Research Corp. | LRK |
| Oct 6, 2026 | K260136 | Forza True Function Laboratory, Inc. | LRK |
| Aug 27, 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) Ram.Shaw Pte., Ltd., SG | LRK |
| Jul 31, 2026 | K261912 | SnØreNegatØr DnB Innovations, LLC | LRK |
| Jun 12, 2026 | K261366 | Virtus Somnomed, Inc. | LRK |
| Jun 11, 2026 | K261251 | Snorbliss® Anti-Snoring Device Endeavor Commerce, LLC | LRK |
| May 14, 2026 | K261134 | Dormiva Anti-Snoring Mouth Guard Koncept Innovators, Inc. | LRK |
| Apr 10, 2026 | K252942 | ShaeferH Shaeferh, LLC | LRK |
| Mar 3, 2026 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) Ram.Shaw Pte. , Ltd., SG | LRK |
| Mar 2, 2026 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) Myofunctional Research Co., AU | LRK |
| Dec 18, 2025 | K252976 | Park Dental Nylon MAD Park Dental Research Corp. | LRK |
| Dec 5, 2025 | K253868 | QuietLab Pro QuietLab, LLC | LRK |
| Nov 25, 2025 | K252161 | Hushd Avera Good Sleep CO Pte , Ltd., SG | LRK |
| Nov 6, 2025 | K252525 | AIO Breathe Aiomega, LLC | LRK |
| Nov 3, 2025 | K252698 | NightGuard Aire Max Nightguard Express, LLC | LRK |
| Oct 29, 2025 | K253355 | Difiney Advanced Anti Snoring Device 4.0 Fissiontech, LLC | LRK |
| Oct 24, 2025 | K251784 | Hushd Pro Z-Link Good Sleep CO Pte , Ltd., SG | LRK |
| Oct 22, 2025 | K251628 | Mandibular Advancement Device L07 Dcstar, Inc. | LRK |
| Oct 3, 2025 | K250028 | Anti Snore Mouthpiece Dongguan Yiyao Science & Technology Development Co., Ltd., CN | LRK |
| Sep 17, 2025 | K243752 | Double Tube Herbst Appliance The Tmj Clinic PC | LRK |
| Sep 11, 2025 | K252374 | Nylon flexTAP(R) Airway Technologies D/B/A Airway Management | LRK |
| Sep 4, 2025 | K250353 | Oniris; Oniris Plus Oniris, FR | LRK |
| May 19, 2025 | K250122 | SleepRight Snore Aid Splintek, Inc. | LRK |
| May 8, 2025 | K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue Fissiontech, LLC | LRK |
| Sep 16, 2024 | K234089 | DNA Appliance Vivos Therapeutics | LRK |
| May 9, 2024 | K232025 | Hushd Pro Avera Good Sleep CO Pte , Ltd., SG | LRK |
| May 3, 2024 | K232735 | EMA 3D Ema Sleep Incorporated | LRK |
| Apr 18, 2024 | K233850 | Difiney Anti Snoring Device Fissiontech, LLC | LRK |
| Feb 14, 2024 | K240427 | airVata Gelb Practice Solutions, Inc. | LRK |
| Jan 16, 2024 | K231138 | Aniti-Snore Mouthguard+ Oscimed SA, CH | LRK |
| Nov 28, 2023 | K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) Vivos Therapeutics, Inc. | LRK |
| Nov 14, 2023 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) Prismatik Dentalcraft, Inc. | LRK |
| Sep 18, 2023 | K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece Innovative Health Technologies (Nz), Ltd., NZ | LRK |
| Sep 1, 2023 | K223901 | ApneaRX Pro Apnea Sciences Coporation | LRK |
| May 10, 2023 | K223624 | Emerald Herbst Island Dental Lab, Inc Dba Emerald Dental | LRK |
| Dec 30, 2022 | K222872 | DNA Appliance Vivos Therapeutics, Inc. | LRK |
| Dec 2, 2022 | K220688 | SilentZPro 2.0 Shinrin-Yoku Traders, LLC | LRK |
| Nov 10, 2022 | K222475 | SNOR LOCK Solbaro Co., Ltd., KR | LRK |
| Oct 27, 2022 | K221322 | CUSTMBITE Snoring System Dental Choice Holdings, LLC | LRK |
| Oct 24, 2022 | K222127 | Soft Palate Elevator The Tmj Clinic PC | LRK |
| Oct 6, 2022 | K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring Prosomnus Sleep Technologies | LRK |
| Sep 8, 2022 | K220330 | Soundly Anti Snoring Device Greystone Ip, Ltd., IE | LRK |
| Jun 15, 2022 | K213088 | ZQuiet Advance Sleeping Well, LLC | LRK |
| May 31, 2022 | K214096 | Respire Clear Respire Medical, LLC | LRK |
| Feb 15, 2022 | K210636 | Morpheus S4S UK , Ltd., GB | LRK |
| Jan 27, 2022 | K213475 | Elevo Snoring Intervention Set Zelegent, Inc. | LRK |
| Oct 26, 2021 | K211069 | EndSnorZ Sleep Appliance Prismatik Dentalcraft, Inc. | LRK |
| Aug 23, 2021 | K200657 | SmartGuard Anti-Snoring Device Smartguard Rx, Inc. | LRK |
| Aug 19, 2021 | K210203 | mmRNA appliance Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | LRK |
| Jul 1, 2021 | K210910 | Snore Bandit Snorebandit, LLC | LRK |
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