Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5570](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5570) → LRK — Device, Anti-Snoring # LRK · Device, Anti-Snoring _Dental · 21 CFR 872.5570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK ## Overview - **Product Code:** LRK - **Device Name:** Device, Anti-Snoring - **Regulation:** [21 CFR 872.5570](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5570) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices. ## Classification Rationale Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.” ## Special Controls *Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.” ## Recent Cleared Devices (20 of 210) Showing 20 most recent of 210 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252942](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252942.md) | ShaeferH | Shaeferh, LLC | Apr 10, 2026 | SESE | | [K253845](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K253845.md) | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | Mar 3, 2026 | SESE | | [K252531](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252531.md) | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | Mar 2, 2026 | SESE | | [K252976](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252976.md) | Park Dental Nylon MAD | Park Dental Research Corp. | Dec 18, 2025 | SESE | | [K253868](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K253868.md) | QuietLab Pro | QuietLab, LLC | Dec 5, 2025 | SESE | | [K252161](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252161.md) | Hushd Avera | Good Sleep CO Pte , Ltd. | Nov 25, 2025 | SESE | | [K252525](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252525.md) | AIO Breathe | Aiomega, LLC | Nov 6, 2025 | SESE | | [K252698](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252698.md) | NightGuard Aire Max | Nightguard Express, LLC | Nov 3, 2025 | SESE | | [K253355](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K253355.md) | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | Oct 29, 2025 | SESE | | [K251784](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K251784.md) | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | Oct 24, 2025 | SESE | | [K251628](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K251628.md) | Mandibular Advancement Device L07 | Dcstar, Inc. | Oct 22, 2025 | SESE | | [K250028](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K250028.md) | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | Oct 3, 2025 | SESE | | [K243752](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K243752.md) | Double Tube Herbst Appliance | The Tmj Clinic PC | Sep 17, 2025 | SESE | | [K252374](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K252374.md) | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | Sep 11, 2025 | SESE | | [K250353](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K250353.md) | Oniris; Oniris Plus | Oniris | Sep 4, 2025 | SESE | | [K250122](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K250122.md) | SleepRight Snore Aid | Splintek, Inc. | May 19, 2025 | SESE | | [K250482](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K250482.md) | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | May 8, 2025 | SESE | | [K234089](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K234089.md) | DNA Appliance | Vivos Therapeutics | Sep 16, 2024 | SESE | | [K232025](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K232025.md) | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | May 9, 2024 | SESE | | [K232735](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK/K232735.md) | EMA 3D | Ema Sleep Incorporated | May 3, 2024 | SESE | ## Top Applicants - Somnomed, Inc. — 7 clearances - Sleeping Well, LLC — 6 clearances - Airway Management, Inc. — 4 clearances - Allen J. Moses, Dds, Ltd. — 4 clearances - Oventus Manufacturing Pty, Ltd. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/LRK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com