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 |
|---|---|---|---|
| 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 |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023-09-01 |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023-05-10 |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D775IBNR0 | Bonded Herbst-Removable Lower | Great Lakes Dental Technologies, Ltd. | 2026-05-07 |
| D775IBNER0 | Bonded Herbst - RPE Removable Lower | Great Lakes Dental Technologies, Ltd. | 2026-05-07 |
| D775IBNE0 | Bonded Herbst - RPE | Great Lakes Dental Technologies, Ltd. | 2026-05-07 |
| D775IBN0 | Bonded Herbst | Great Lakes Dental Technologies, Ltd. | 2026-05-07 |
| D775IBASA0 | Herbst -Banded Upper Or Lower-Single Arch | Great Lakes Dental Technologies, Ltd. | 2026-05-07 |
| 00850022853036 | ProSomnus RPMO2 OSA Device | PROSOMNUS SLEEP TECHNOLOGIES | 2026-04-24 |
| D775IBAE0 | Banded Herbst -RPE | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775INIST0 | Nylon Herbst Sleep | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IIST0 | Telescopic Herbst Sleep | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IBAR0 | Banded Herbst -Removable Lower | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IBAER0 | Banded Herbst-Rpe Remov Lower | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IBAEBN0 | Rpe Bonded Lower | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IBABN0 | Bonded Lower | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| D775IBA0 | Banded Herbst | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| B140035202 | SnoreByte Kit | Braebon Medical Corporation | 2023-06-09 |
| B140351951 | SnoreByte Tray | Braebon Medical Corporation | 2023-06-09 |
| M71004615000 | The Slide® | BIOTEX, INC. | 2023-05-19 |
| 00810002220210 | OASYS (Oral/Nasal Airway System) | JOHN'S DENTAL LABORATORY INC | 2023-03-28 |
| 00372494103469 | SleepTight Rx | Doc Brands, Inc. | 2023-01-03 |
| 00372494103452 | Dentemp SleepTight | Doc Brands, Inc. | 2023-01-03 |
| D866SC0 | Ortho-Tain, Inc | Ortho-Tain, Inc | 2022-12-16 |
| 00071031189521 | Rest Assured | RANIR, LLC | 2021-10-15 |
| M71004610000 | The Slide® | BIOTEX, INC. | 2021-09-01 |
| 00810002220074 | OASYS (Oral/Nasal Airway System) | JOHN'S DENTAL LABORATORY INC | 2020-09-23 |
| 00651080000017 | Meijer | MEIJER, INC. | 2020-04-24 |
| 00651080000000 | Rest Assured | RANIR, LLC | 2020-04-15 |
| 00842326101128 | EMA Custom | The Myerson Company Limited | 2020-03-25 |
| 00842326101135 | EMA Custom | The Myerson Company Limited | 2020-03-25 |
| B406CAT039020 | TD Clip | Zephyr Sleep Technologies Inc | 2019-07-22 |
| B406CAT038020 | TD Clip | Zephyr Sleep Technologies Inc | 2019-07-22 |