Therapeutic devices · 21 CFR 872 Subpart F
Jaw Repositioning Device
FDA device type “Device, Jaw Repositioning”.
- Companies listing it
- 3433 makers
- Brands and models
- 83
- 510(k) clearances
- 272 in five years
- FDA name
- Device, Jaw Repositioning
510(k) clearances per year, 1976–2026
Companies that list LQZ
34 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Vivos Therapeutics, Inc. | United States | Maker | DNA · Vivos mmRNA Appliance · Vivos Vida Sleep | 3 | 2024 |
| Fissiontech LLC | United States | Maker | Advanced Anti Snoring Device 4 Clear/ Advanced Anti Snoring Device 4 Blue | 3 | 2025 |
| ProSomnus Sleep Technologies | United States | Maker | ProSomnus RPMO2 OSA Device · ProSomnus® EVO Sleep and Snore Device · ProSomnus® EVO Sleep and Snore Device with Patient Monitoring | 3 | 2026 |
| Modern Dental Laboratory Co., Ltd. | China | Maker | Emerald Herbst | 2 | 2024 |
| Aiomega, LLC | United States | Maker | AIO BREATHE | 2 | 2025 |
| Koncept Innovators, LLC | United States | Maker | Bright Guard Pro 2 · Dormiva Anti-Snoring Mouth Guard · Eliminator Pro 2 · Intelliguard Pro · +9 | 2 | 2026 |
| EMA-Sleep Inc | United States | Maker | EMA 3D | 1 | 2024 |
| Gergens Orthodontic Lab | United States | Maker | mmRNA appliance | 3 | 2017 |
| Crane Dental Laboratory | United States | Maker | Lamberg SleepWell | 2 | 2019 |
| Selane Products, Inc. | United States | Maker | ApnoDent · ATG/SM-OSA APPLIANCES · Clear Sleep | 2 | 2017 |
| National Dentex LLC | United States | Maker | PM Positioner | 1 | 2012 |
| Sicat GmbH & Co. KG | Germany | Maker | SICAT OPTISLEEP | 1 | 2016 |
| Apnomed, Inc. | United States | Maker | ApnoDent appliance | 1 | 2018 |
| Biotex, Inc. | United States | Maker | The Slide | 1 | 2021 |
| Slow Wave, Inc. | United States | Maker | Slow Wave DS8 | 1 | 2020 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | mmRNA | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Elastomeric Appliance · NAPA Appliance | — | — |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | China | Maker | Bright Guard Pro 2 · Dormiva Anti-Snoring Mouth Guard · Eliminator Pro 2 · Intelliguard Pro · +9 | — | — |
| Ortho Solutions LC | United States | Maker | Respire Medical · White Night | — | — |
| Digital Dental Depot Limited | Hong Kong SAR China | Maker | Advanced Anti-Snoring Device 4 Clear/Blue · Device, anti-snoring · Device, jaw repositioning | — | — |
| Shenzhen Sany Pioneer Technology Co.,Ltd | China | Maker | Everness Anti Snoring Mouthpiece L07 · Innoflow Anti Snoring Mouthpiece L07 · Innoflow Anti Snoring Mouthpiece L09 · Joybloom Anti Snoring Mouthpiece L09 · +4 | — | — |
| Shenzhen Osmiler Intelligent Technology Co., Ltd. | China | Maker | Device, anti-snoring · Device, jaw repositioning · Medical device data system · Oximeter · +1 | — | — |
| Aurum Group Ltd. | Canada | Maker | DNA · Snoring device | — | — |
| Johns Dental Lab | United States | Maker | EMA 3D · Vivos DNA · Vivos mmRNA | — | — |
| Apex Dental Sleep Lab | United States | Maker | EMA 3D · Kava · MMRNA | — | — |
| Digital Dental Depot | China | Maker | Device, jaw repositioning | — | — |
| Burbank Dental Lab | United States | Maker | — | — | — |
| Oral Arts Laboratory, Inc. | United States | Maker | EMA 3D | — | — |
| Dental Prosthetic Services, Inc. | United States | Maker | EMA 3D | — | — |
| Shun Hsiang Plastic Co.,ltd. | Taiwan | Maker | Advanced Anti Snoring Device 4 Clear/ Advanced Anti Snoring Device 4 Blue | — | — |
| Gelb Practice | United States | Maker | airVataTM | — | — |
| Island Dental Lab dba Emerald Dental Lab | United States | Maker | Emerald Herbst | — | — |
| Sleep Joy International LLC | United States | Maker | LambergSleepWell-Smartrusion (LSW-S) | — | — |
| Sleepcare, LLC | United States | Repacker / relabeler | Daybreak Device Neo | 1 | 2026 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Feb 2024 | K233754 | AIO Breathe | Aiomega, LLC |
| 12 Jul 2023 | K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC |
| 20 Jul 2021 | K203712 | The Slide | Biotex, Inc. |
| 2 Oct 2020 | K191320 | Slow Wave DS8 | Slow Wave, Inc. |
| 28 Jan 2020 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC |
| 27 Jul 2017 | K162816 | SML-OSA2 Appliances | Selane Products, Inc. |
| 26 Aug 2013 | K130130 | ATG/SM-OSA APPLIANCES | Selane Products, Inc. |
| 6 Jun 2012 | K112627 | MILLENIUM ANTI-SNORING DEVICE | Millenium Dental Laboratory, Inc. |
| 4 Jun 2012 | K112766 | SNORKEL | Fellmar Company |
| 1 Dec 2011 | K113201 | NARVAL CC | Resmed Sas |
| 11 Sep 2009 | K090911 | IST SNORING APPLIANCE | Dental Crafters Inc. |
| 24 Jun 2009 | K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds |
| 26 May 2006 | K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds |
| 3 Jan 2006 | K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) | Bryan Keropian Dds |
| 30 Dec 2005 | K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds |
| 28 Feb 2005 | K032410 | SNORENTI | James P Boyd |
| 18 Dec 1997 | K971818 | SNOREX | Snorex (Nz) , Ltd. |
| 9 May 1996 | K960673 | OSAP | Snorefree, Inc. |
| 8 Feb 1996 | K955503 | ADJUSTABLE PM POSITIONER | Jonathan A. Parker, D.D.S. |
| 15 Sep 1995 | K953293 | PM POSITIONER | Jonathan A. Parker, D.D.S. |
| 15 Jun 1995 | K945820 | DESRA | D.S.R.A., Inc. |
| 14 Jun 1995 | K946112 | ELASTOMERIC SLEEP APPLIANCE | Village Park Orthodontics |
| 10 Feb 1995 | K932932 | SNOREMASTER SNORE REMEDY | The Snoremaster Co. |
| 9 Feb 1994 | K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. |
| 19 Sep 1990 | K902790 | NAPA | G-Ortho Lab |
| 11 May 1988 | K880956 | SNOAR(TM) OPEN AIRWAY APPLIANCE | Kent J. Toone, D.D.S. |
| 4 Mar 1987 | K870501 | THE EQUALIZER AIRWAY DEVICE | Sleep Renewal, Inc. |
Official records: FDA product classification for LQZ · 21 CFR 872.5570.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026