FDA Product Code
FDA Product Code LRK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5570
510(k) Clearances — 215 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | 2026-08-27 | Special | PDF ↗ |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026-07-31 | Traditional | PDF ↗ |
| K261366 | Virtus | Somnomed, Inc. | 2026-06-12 | Special | PDF ↗ |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | 2026-06-11 | Traditional | PDF ↗ |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | 2026-05-14 | Special | PDF ↗ |
| K252942 | ShaeferH | Shaeferh, LLC | 2026-04-10 | Traditional | PDF ↗ |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | 2026-03-03 | Traditional | PDF ↗ |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026-03-02 | Traditional | PDF ↗ |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 | Traditional | PDF ↗ |
| K253868 | QuietLab Pro | QuietLab, LLC | 2025-12-05 | Traditional | PDF ↗ |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 2025-11-25 | Abbreviated | PDF ↗ |
| K252525 | AIO Breathe | Aiomega, LLC | 2025-11-06 | Abbreviated | PDF ↗ |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025-11-03 | Traditional | PDF ↗ |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | 2025-10-29 | Special | PDF ↗ |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | 2025-10-24 | Traditional | PDF ↗ |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025-10-22 | Traditional | PDF ↗ |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 | Traditional | PDF ↗ |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | 2025-09-17 | Abbreviated | PDF ↗ |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | 2025-09-11 | Special | PDF ↗ |
| K250353 | Oniris; Oniris Plus | Oniris | 2025-09-04 | Traditional | PDF ↗ |
| K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025-05-19 | Traditional | PDF ↗ |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | 2025-05-08 | Traditional | PDF ↗ |
| K234089 | DNA Appliance | Vivos Therapeutics | 2024-09-16 | Traditional | PDF ↗ |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | 2024-05-09 | Traditional | PDF ↗ |
| K232735 | EMA 3D | Ema Sleep Incorporated | 2024-05-03 | Traditional | PDF ↗ |
| K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024-04-18 | Traditional | PDF ↗ |
| K240427 | airVata | Gelb Practice Solutions, Inc. | 2024-02-14 | Traditional | PDF ↗ |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | 2024-01-16 | Traditional | PDF ↗ |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023-11-28 | Traditional | PDF ↗ |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Prismatik Dentalcraft, Inc. | 2023-11-14 | Special | PDF ↗ |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. | 2023-09-18 | Traditional | PDF ↗ |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023-09-01 | Special | PDF ↗ |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023-05-10 | Traditional | PDF ↗ |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022-12-30 | Traditional | PDF ↗ |
| K220688 | SilentZPro 2.0 | Shinrin-Yoku Traders, LLC | 2022-12-02 | Traditional | PDF ↗ |
| K222475 | SNOR LOCK | Solbaro Co., Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K221322 | CUSTMBITE Snoring System | Dental Choice Holdings, LLC | 2022-10-27 | Traditional | PDF ↗ |
| K222127 | Soft Palate Elevator | The Tmj Clinic PC | 2022-10-24 | Abbreviated | PDF ↗ |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies | 2022-10-06 | Abbreviated | PDF ↗ |
| K220330 | Soundly Anti Snoring Device | Greystone Ip, Ltd. | 2022-09-08 | Abbreviated | PDF ↗ |
| K213088 | ZQuiet Advance | Sleeping Well, LLC | 2022-06-15 | Traditional | PDF ↗ |
| K214096 | Respire Clear | Respire Medical, LLC | 2022-05-31 | Traditional | PDF ↗ |
| K210636 | Morpheus | S4S UK , Ltd. | 2022-02-15 | Traditional | PDF ↗ |
| K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | 2022-01-27 | Traditional | PDF ↗ |
| K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | 2021-10-26 | Traditional | PDF ↗ |
| K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | 2021-08-23 | Traditional | PDF ↗ |
| K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | 2021-08-19 | Abbreviated | PDF ↗ |
| K210910 | Snore Bandit | Snorebandit, LLC | 2021-07-01 | Traditional | PDF ↗ |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021-06-16 | Special | PDF ↗ |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Meris Investment Group | 2021-03-10 | Traditional | PDF ↗ |
| K203477 | Classic | Orthoapnea S.L. | 2021-02-25 | Traditional | PDF ↗ |
| K203462 | Advanced Dental Appliance | Dasoft Partners | 2021-02-19 | Abbreviated | PDF ↗ |
| K202651 | NOA Sleep Apnea and Snoring Device | Orthoapnea S.L. | 2021-02-12 | Traditional | PDF ↗ |
| K201719 | Vital Sleep | The Snore Reliever Company, LLC | 2021-01-14 | Abbreviated | PDF ↗ |
| K201484 | Somnos Anti-Snoring Mouth Guard | Koncept Innovators, LLC | 2020-11-23 | Traditional | PDF ↗ |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies, Inc. | 2020-11-20 | Special | PDF ↗ |
| K202499 | Diamond Digital Sleep Orthotic (DDSO) | Diamond Orthotic Laboratory | 2020-09-03 | Traditional | PDF ↗ |
| K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | 2020-02-05 | Special | PDF ↗ |
| K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution) | Mpowrx Health and Wellness Products 2012, Inc. | 2020-01-03 | Traditional | PDF ↗ |
| K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019-12-11 | Traditional | PDF ↗ |
| K181416 | Sapphire Dorsal Comfort Fit | Crane Dental Laboratory, Inc. | 2019-09-17 | Traditional | PDF ↗ |
| K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019-08-29 | Traditional | PDF ↗ |
| K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | 2019-07-17 | Traditional | PDF ↗ |
| K190687 | Twilite Appliance | Stephen J Harkins, Dds, PC | 2019-07-02 | Traditional | PDF ↗ |
| K190051 | TD Clip | Zephyr Sleep Technologies, Inc. | 2019-06-07 | Abbreviated | PDF ↗ |
| K183443 | SomnoDent Avant | Somnomed, Inc. | 2019-05-08 | Abbreviated | PDF ↗ |
| K190058 | PureSleep (OTC use) | Sleep Science Partners, Inc. | 2019-04-11 | Traditional | PDF ↗ |
| K173064 | ZAPnea Oral Appliance | B. Fareid, Dds, PC | 2019-03-08 | Traditional | PDF ↗ |
| K182661 | Kava and Kava with Herbst | Sketchpad Innovations, LLC | 2019-02-13 | Traditional | PDF ↗ |
| K180691 | TrueDorsal Devices | True Function Laboratory, Inc. | 2019-02-11 | Traditional | PDF ↗ |
| K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019-01-24 | Traditional | PDF ↗ |
| K182202 | SLEEPAPP | Comfort Acrylics, Inc. | 2019-01-11 | Abbreviated | PDF ↗ |
| K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | 2018-12-06 | Traditional | PDF ↗ |
| K181123 | ApnoDent Appliance | Apnomed, Inc. | 2018-11-21 | Traditional | PDF ↗ |
| K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | 2018-11-16 | Traditional | PDF ↗ |
| K181482 | myTAP2 | Airway Management, Inc. | 2018-08-31 | Traditional | PDF ↗ |
| K172991 | Advanced Dental Applicance | Dasoft Partners | 2018-07-10 | Abbreviated | PDF ↗ |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance | Moses Appliances, LLC | 2018-06-26 | Traditional | PDF ↗ |
| K180124 | ZQuiet | Sleeping Well, LLC | 2018-06-12 | Abbreviated | PDF ↗ |
| K172760 | REST EAZY Appliance | Insert Molding Solutions, Inc. | 2018-03-26 | Traditional | PDF ↗ |
| K171576 | The Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. | 2018-02-22 | Abbreviated | PDF ↗ |
| K171529 | Snorer's Friend | Scope Healthcare Technologies Pty, Ltd. | 2018-01-02 | Abbreviated | PDF ↗ |
| K170053 | Meridian PM | The Center For Craniofacial & Dental Sleep Medicine | 2017-11-28 | Abbreviated | PDF ↗ |
| K170578 | True Function Adjustable Herbst Appliances | True Function Laboratory, Inc. | 2017-11-24 | Abbreviated | PDF ↗ |
| K170825 | SnoreRx | Apnea Sciences Corporation | 2017-08-18 | Abbreviated | PDF ↗ |
| K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017-07-11 | Special | PDF ↗ |
| K163580 | ASD Oral Appliances | American Sleep Dentistry | 2017-06-08 | Traditional | PDF ↗ |
| K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017-05-26 | Traditional | PDF ↗ |
| K161980 | Fuselier Intraoral Nighttime Device (FIND) | Fuselier Enterprises, LLC | 2017-02-07 | Traditional | PDF ↗ |
| K162192 | BluePro | Bluesom | 2016-12-15 | Traditional | PDF ↗ |
| K152660 | HYPNOSPAD | Somnics, Inc. | 2016-11-09 | Traditional | PDF ↗ |
| K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016-09-23 | Special | PDF ↗ |
| K162306 | SomnoDent ALPHA | Somnomed, Inc. | 2016-09-20 | Abbreviated | PDF ↗ |
| K160531 | Noiselezz | Firma Ingemarsson | 2016-09-01 | Abbreviated | PDF ↗ |
| K153200 | SnoreRx | Apnea Sciences Corporation | 2016-08-09 | Abbreviated | PDF ↗ |
| K160123 | Apinator | Allen J. Moses, Dds, Ltd. | 2016-07-12 | Abbreviated | PDF ↗ |
| K153291 | SICAT OPTISLEEP | Sicat GmbH & Co. KG | 2016-03-31 | Abbreviated | PDF ↗ |
| K150566 | Oniris | Sas Oniris | 2016-03-21 | Traditional | PDF ↗ |
| K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016-03-17 | Traditional | PDF ↗ |
| K152292 | Respire Blue Series-EF | Respire Medical Holding | 2015-12-07 | Traditional | PDF ↗ |
Product code LRK · Class II · Dental. Data: openFDA.