Device, Anti-Snoring
FDA product code LRK · Class II (moderate risk) · 21 CFR 872.5570 · Dental
215510(k) clearances
0PMA approvals
10recalls
Manufacturers
- Somnomed, Inc. 9
- Sleeping Well, LLC 6
- Always More Marketing, Inc. 4
- Oventus Manufacturing Pty, Ltd. 4
- Airway Management, Inc. 4
- Allen J. Moses, Dds, Ltd. 4
- Prismatik Dentalcraft, Inc. 4
- Dental Imagineers, LLC 3
- Fissiontech, LLC 3
- Vivos Therapeutics, Inc. 3
- Good Sleep CO Pte , Ltd. 3
- Respire Medical 3
- Respire Medical Holding 3
- Zephyr Sleep Technologies 2
- Ranir, LLC 2
- Influence, Inc. 2
- Nellcor Puritan Bennett, Inc. 2
- Medtronic Xomed, Inc. 2
- Tomed Dr. Toussaint GmbH 2
- Snore - Ezzer 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)LRK · Special | Ram.Shaw Pte., Ltd. | 08/27/2026SE |
| K261912 | SnØreNegatØrLRK · Traditional | DnB Innovations, LLC | 07/31/2026SE |
| K261366 | VirtusLRK · Special | Somnomed, Inc. | 06/12/2026SE |
| K261251 | Snorbliss® Anti-Snoring DeviceLRK · Traditional | Endeavor Commerce, LLC | 06/11/2026SE |
| K261134 | Dormiva Anti-Snoring Mouth GuardLRK · Special | Koncept Innovators, Inc. | 05/14/2026SE |
| K252942 | ShaeferHLRK · Traditional | Shaeferh, LLC | 04/10/2026SE |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)LRK · Traditional | Ram.Shaw Pte. , Ltd. | 03/03/2026SE |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)LRK · Traditional | Myofunctional Research Co. | 03/02/2026SE |
| K252976 | Park Dental Nylon MADLRK · Traditional | Park Dental Research Corp. | 12/18/2025SE |
| K253868 | QuietLab ProLRK · Traditional | QuietLab, LLC | 12/05/2025SE |
| K252161 | Hushd AveraLRK · Abbreviated | Good Sleep CO Pte , Ltd. | 11/25/2025SE |
| K252525 | AIO BreatheLRK · Abbreviated | Aiomega, LLC | 11/06/2025SE |
| K252698 | NightGuard Aire MaxLRK · Traditional | Nightguard Express, LLC | 11/03/2025SE |
| K253355 | Difiney Advanced Anti Snoring Device 4.0LRK · Special | Fissiontech, LLC | 10/29/2025SE |
| K251784 | Hushd Pro Z-LinkLRK · Traditional | Good Sleep CO Pte , Ltd. | 10/24/2025SE |
| K251628 | Mandibular Advancement Device L07LRK · Traditional | Dcstar, Inc. | 10/22/2025SE |
| K250028 | Anti Snore MouthpieceLRK · Traditional | Dongguan Yiyao Science & Technology Development… | 10/03/2025SE |
| K243752 | Double Tube Herbst ApplianceLRK · Abbreviated | The Tmj Clinic PC | 09/17/2025SE |
| K252374 | Nylon flexTAP(R)LRK · Special | Airway Technologies D/B/A Airway Management | 09/11/2025SE |
| K250353 | Oniris; Oniris PlusLRK · Traditional | Oniris | 09/04/2025SE |
| K250122 | SleepRight Snore AidLRK · Traditional | Splintek, Inc. | 05/19/2025SE |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueLRK · Traditional | Fissiontech, LLC | 05/08/2025SE |
| K234089 | DNA ApplianceLRK · Traditional | Vivos Therapeutics | 09/16/2024SE |
| K232025 | Hushd Pro AveraLRK · Traditional | Good Sleep CO Pte , Ltd. | 05/09/2024SE |
| K232735 | Ema 3DLRK · Traditional | Ema Sleep Incorporated | 05/03/2024SE |
| K233850 | Difiney Anti Snoring DeviceLRK · Traditional | Fissiontech, LLC | 04/18/2024SE |
| K240427 | airVataLRK · Traditional | Gelb Practice Solutions, Inc. | 02/14/2024SE |
| K231138 | Aniti-Snore Mouthguard+LRK · Traditional | Oscimed SA | 01/16/2024SE |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA)LRK · Traditional | Vivos Therapeutics, Inc. | 11/28/2023SE |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)LRK · Special | Prismatik Dentalcraft, Inc. | 11/14/2023SE |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) MouthpieceLRK · Traditional | Innovative Health Technologies (Nz), Ltd. | 09/18/2023SE |
| K223901 | ApneaRX ProLRK · Special | Apnea Sciences Coporation | 09/01/2023SE |
| K223624 | Emerald HerbstLRK · Traditional | Island Dental Lab, Inc Dba Emerald Dental | 05/10/2023SE |
| K222872 | DNA ApplianceLRK · Traditional | Vivos Therapeutics, Inc. | 12/30/2022SE |
| K220688 | SilentZPro 2.0LRK · Traditional | Shinrin-Yoku Traders, LLC | 12/02/2022SE |
| K222475 | Snor LockLRK · Traditional | Solbaro Co., Ltd. | 11/10/2022SE |
| K221322 | CUSTMBITE Snoring SystemLRK · Traditional | Dental Choice Holdings, LLC | 10/27/2022SE |
| K222127 | Soft Palate ElevatorLRK · Abbreviated | The Tmj Clinic PC | 10/24/2022SE |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…LRK · Abbreviated | Prosomnus Sleep Technologies | 10/06/2022SE |
| K220330 | Soundly Anti Snoring DeviceLRK · Abbreviated | Greystone Ip, Ltd. | 09/08/2022SE |
| K213088 | ZQuiet AdvanceLRK · Traditional | Sleeping Well, LLC | 06/15/2022SE |
| K214096 | Respire ClearLRK · Traditional | Respire Medical, LLC | 05/31/2022SE |
| K210636 | MorpheusLRK · Traditional | S4S UK , Ltd. | 02/15/2022SE |
| K213475 | Elevo Snoring Intervention SetLRK · Traditional | Zelegent, Inc. | 01/27/2022SE |
| K211069 | EndSnorZ Sleep ApplianceLRK · Traditional | Prismatik Dentalcraft, Inc. | 10/26/2021SE |
| K200657 | SmartGuard Anti-Snoring DeviceLRK · Traditional | Smartguard Rx, Inc. | 08/23/2021SE |
| K210203 | mmRNA applianceLRK · Abbreviated | Vivos Therapeutics, Inc. (Formerly Vivos… | 08/19/2021SE |
| K210910 | Snore BanditLRK · Traditional | Snorebandit, LLC | 07/01/2021SE |
| K210694 | Silent Nite Sleep Appliance with the Glidewell HingeLRK · Special | Prismatik Dentalcraft, Inc. | 06/16/2021SE |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…LRK · Traditional | Meris Investment Group | 03/10/2021SE |
| K203477 | ClassicLRK · Traditional | Orthoapnea S.L. | 02/25/2021SE |
| K203462 | Advanced Dental ApplianceLRK · Abbreviated | Dasoft Partners | 02/19/2021SE |
| K202651 | NOA Sleep Apnea and Snoring DeviceLRK · Traditional | Orthoapnea S.L. | 02/12/2021SE |
| K201719 | Vital SleepLRK · Abbreviated | The Snore Reliever Company, LLC | 01/14/2021SE |
| K201484 | Somnos Anti-Snoring Mouth GuardLRK · Traditional | Koncept Innovators, LLC | 11/23/2020SE |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…LRK · Special | Prosomnus Sleep Technologies, Inc. | 11/20/2020SE |
| K202499 | Diamond Digital Sleep Orthotic (DDSO)LRK · Traditional | Diamond Orthotic Laboratory | 09/03/2020SE |
| K192127 | Respire Pink AT (Hard, Hard/Soft, EF)LRK · Special | Respire Medical Holdings | 02/05/2020SE |
| K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution)LRK · Traditional | Mpowrx Health and Wellness Products 2012, Inc. | 01/03/2020SE |
| K191618 | SleepTight Mouthpiece STZLRK · Traditional | Michael D Williams Dds PA | 12/11/2019SE |
| K181416 | Sapphire Dorsal Comfort FitLRK · Traditional | Crane Dental Laboratory, Inc. | 09/17/2019SE |
| K190236 | O2Vent OptimaLRK · Traditional | Oventus Manufacturing Pty, Ltd. | 08/29/2019SE |
| K183270 | Silent Nite slLRK · Traditional | Prismatik Dentalcraft, Inc. | 07/17/2019SE |
| K190687 | Twilite ApplianceLRK · Traditional | Stephen J Harkins, Dds, PC | 07/02/2019SE |
| K190051 | TD ClipLRK · Abbreviated | Zephyr Sleep Technologies, Inc. | 06/07/2019SE |
| K183443 | SomnoDent AvantLRK · Abbreviated | Somnomed, Inc. | 05/08/2019SE |
| K190058 | PureSleep (OTC use)LRK · Traditional | Sleep Science Partners, Inc. | 04/11/2019SE |
| K173064 | ZAPnea Oral ApplianceLRK · Traditional | B. Fareid, Dds, PC | 03/08/2019SE |
| K182661 | Kava and Kava with HerbstLRK · Traditional | Sketchpad Innovations, LLC | 02/13/2019SE |
| K180691 | TrueDorsal DevicesLRK · Traditional | True Function Laboratory, Inc. | 02/11/2019SE |
| K182312 | Zyppah Anti-Snoring DeviceLRK · Traditional | Always More Marketing | 01/24/2019SE |
| K182202 | SleepappLRK · Abbreviated | Comfort Acrylics, Inc. | 01/11/2019SE |
| K181107 | Elevo® Kit Snoring Intervention DeviceLRK · Traditional | Zelegent, Inc. | 12/06/2018SE |
| K181123 | ApnoDent ApplianceLRK · Traditional | Apnomed, Inc. | 11/21/2018SE |
| K181396 | Oral Device OA, Oral Device SLRK · Traditional | Passion For Life Healthcare (Uk) Limited | 11/16/2018SE |
| K181482 | myTAP2LRK · Traditional | Airway Management, Inc. | 08/31/2018SE |
| K172991 | Advanced Dental ApplicanceLRK · Abbreviated | Dasoft Partners | 07/10/2018SE |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick applianceLRK · Traditional | Moses Appliances, LLC | 06/26/2018SE |
| K180124 | ZQuietLRK · Abbreviated | Sleeping Well, LLC | 06/12/2018SE |
| K172760 | REST EAZY ApplianceLRK · Traditional | Insert Molding Solutions, Inc. | 03/26/2018SE |
| K171576 | The Panthera Anti-Snoring X3 DeviceLRK · Abbreviated | Panthera Dental, Inc. | 02/22/2018SE |
| K171529 | Snorer's FriendLRK · Abbreviated | Scope Healthcare Technologies Pty, Ltd. | 01/02/2018SE |
| K170053 | Meridian PMLRK · Abbreviated | The Center For Craniofacial & Dental Sleep… | 11/28/2017SE |
| K170578 | True Function Adjustable Herbst AppliancesLRK · Abbreviated | True Function Laboratory, Inc. | 11/24/2017SE |
| K170825 | SnoreRxLRK · Abbreviated | Apnea Sciences Corporation | 08/18/2017SE |
| K171316 | O2Vent WLRK · Special | Oventus Manufacturing Pty, Ltd. | 07/11/2017SE |
| K163580 | ASD Oral AppliancesLRK · Traditional | American Sleep Dentistry | 06/08/2017SE |
| K170692 | Respire Pink Series with DentiTracLRK · Traditional | Respire Medical Holding | 05/26/2017SE |
| K161980 | Fuselier Intraoral Nighttime Device (FIND)LRK · Traditional | Fuselier Enterprises, LLC | 02/07/2017SE |
| K162192 | BlueProLRK · Traditional | Bluesom | 12/15/2016SE |
| K152660 | HypnospadLRK · Traditional | Somnics, Inc. | 11/09/2016SE |
| K161832 | O2VENT TLRK · Special | Oventus Manufacturing Pty, Ltd. | 09/23/2016SE |
| K162306 | SomnoDent ALPHALRK · Abbreviated | Somnomed, Inc. | 09/20/2016SE |
| K160531 | NoiselezzLRK · Abbreviated | Firma Ingemarsson | 09/01/2016SE |
| K153200 | SnoreRxLRK · Abbreviated | Apnea Sciences Corporation | 08/09/2016SE |
| K160123 | ApinatorLRK · Abbreviated | Allen J. Moses, Dds, Ltd. | 07/12/2016SE |
| K153291 | Sicat OptisleepLRK · Abbreviated | Sicat GmbH & Co. KG | 03/31/2016SE |
| K150566 | OnirisLRK · Traditional | Sas Oniris | 03/21/2016SE |
| K160234 | OventLRK · Traditional | Oventus Manufacturing Pty, Ltd. | 03/17/2016SE |
| K152292 | Respire Blue Series-EFLRK · Traditional | Respire Medical Holding | 12/07/2015SE |
| K152159 | Oravan HerbstLRK · Traditional | Oravanosa, LLC | 10/29/2015SE |
| K150572 | Respire Pink Series-Herbst-EFLRK · Traditional | Respire Medical Holding | 08/27/2015SE |
| K142651 | The Moses Express applianceLRK · Traditional | Allen J. Moses, Dds, Ltd. | 07/17/2015SE |
| K150941 | Somnowell Mandibular Advancement Appliance (MAA)LRK · Traditional | Somnowell , Ltd. | 05/22/2015SE |
| K143591 | Dorsal ApplianceLRK · Traditional | Gergens Orthodontic Lab | 04/15/2015SE |
| K143244 | The Panthera Anti-Snoring DeviceLRK · Traditional | Panthera Dental, Inc. | 12/15/2014SE |
| K140663 | TherasnoreLRK · Abbreviated | Distar, LLC | 12/12/2014SE |
| K133390 | NDX Dorsal ApplianceLRK · Traditional | Institute For Quality Resource Management | 10/16/2014SE |
| K140429 | Crane Acrylic Herbst ApplianceLRK · Traditional | Crane Dental Laboratory, Inc. | 09/11/2014SE |
| K140777 | Zquiet-SaLRK · Traditional | Sleeping Well, LLC | 07/25/2014SE |
| K133683 | MICR02 Osa DeviceLRK · Traditional | Microdental, Inc. | 07/24/2014SE |
| K140435 | Medley GoldLRK · Traditional | American Dental Sleep Medicine, Ip, LLC | 06/26/2014SE |
| K140278 | Somnodent Fusion, Classic; Somnodent Fusion, FlexLRK · Traditional | Somnomed, Inc. | 06/20/2014SE |
| K132506 | Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep EasyLRK · Traditional | Michael D Williams Dds PA | 05/29/2014SE |
| K130067 | Mrna ApplianceLRK · Abbreviated | Biomodeling Solutions, Lls | 05/08/2014SE |
| K132933 | The Moses Elite ApplianceLRK · Special | Allen J. Moses, Dds, Ltd. | 04/25/2014SE |
| K130797 | Luco Hybrid Osa ApplianceLRK · Traditional | Luco Hybrid Osa Appliance, Inc. | 12/18/2013SE |
| K130504 | Asa Oral AppliancesLRK · Traditional | American Sleep Association | 10/18/2013SE |
| K131138 | Respire Pink Series - HerbstLRK · Traditional | Respire Medical | 09/09/2013SE |
| K113126 | Acrylic Herbst ApplianceLRK · Traditional | Gergens Orthodontic Lab | 07/17/2013SE |
| K130558 | Somnodent Herbst; Classic, FlexLRK · Special | Somnomed, Inc. | 05/17/2013SE |
| K123410 | Healthy Sleep ApplianceLRK · Traditional | Healthy Sleep Dental Laboratory | 04/05/2013SE |
| K121285 | Oravan OsaLRK · Traditional | New Jersey Snoring Solutions | 03/08/2013SE |
| K122391 | Medtronic Xomed, Inc.LRK · Traditional | Medtronic Xomed, Inc. | 01/10/2013SE |
| K113516 | Therasom-CastLRK · Traditional | Family Dental Services, P.C. | 01/04/2013SE |
| K122475 | Zquiet Pro-PlusLRK · Traditional | Sleeping Well, LLC | 12/07/2012SE |
| K121344 | Nu SleepLRK · Abbreviated | Rh Associates, LLC | 10/17/2012SE |
| K121761 | Somnoguard SP SoftLRK · Traditional | Tomed Dr. Toussaint GmbH | 09/28/2012SE |
| K120372 | DR Greenburgs Hybrid VacuumLRK · Abbreviated | Always More Marketing, Inc. | 06/27/2012SE |
| K120371 | DR Greenburgs Hybrid AcrylicLRK · Abbreviated | Always More Marketing, Inc. | 06/27/2012SE |
| K113022 | PuresleepLRK · Traditional | Sleep Science Partners, Inc. | 06/11/2012SE |
| K121340 | Somnodent G2LRK · Traditional | Somnomed, Inc. | 05/30/2012SE |
| K103704 | Remotely Controlled Mandibular Positioner, RCMPLRK · Abbreviated | Zephyr Sleep Technologies, Inc. | 03/23/2012SE |
| K113569 | ApnearxLRK · Abbreviated | Apnea Science Corporation | 03/01/2012SE |
| K110623 | Pillar Palatal Implant SystemLRK · Traditional | Medtronic Xomed, Inc. | 02/10/2012SE |
| K111680 | Dr. Greensburg's HybridLRK · Abbreviated | Always More Marketing, Inc. | 12/23/2011SE |
| K112205 | Snorerx 9.0LRK · Abbreviated | Consumer Health Products, Inc. | 11/16/2011SE |
| K111207 | Respire Blue SeriesLRK · Abbreviated | Respire Medical | 08/23/2011SE |
| K111110 | Apnea GuardLRK · Traditional | Advanced Brain Monitoring, Inc. | 07/22/2011SE |
| K111009 | Acrylic Herbst ApplianceLRK · Traditional | Embassy Dental Laboratory | 07/22/2011SE |
| K102463 | Good NightLRK · Abbreviated | Larry V Connell, Dmd | 05/25/2011SE |
| K101155 | Auradorm (Neuromuscular Sleep)LRK · Traditional | Sleepwright | 05/12/2011SE |
| K102521 | Pantino Pro PositinerLRK · Traditional | Somnomed, Inc. | 03/28/2011SE |
| K103004 | Snore GuardLRK · Special | Ranir, LLC | 02/25/2011SE |
| K103076 | DynaflexLRK · Traditional | Dyna Flex | 02/23/2011SE |
| K100185 | Sleep AppLRK · Traditional | Sleep Medicine Network, Inc. | 11/19/2010SE |
| K102118 | Snore Guard AdvanceLRK · Special | Ranir, LLC | 09/08/2010SE |
| K101709 | Lambergsleepwell- Smartrusion (Lsw-S)LRK · Abbreviated | Steven B. Lamberg, Dds | 08/18/2010SE |
| K093407 | Zquiet MouthpieceLRK · Traditional | Sleeping Well, LLC | 06/22/2010SE |
| K093340 | Pasr/QuietniteLRK · Abbreviated | Exact Supplies , Ltd. | 06/11/2010SE |
| K093710 | The Moses ApplianceLRK · Abbreviated | Allen J. Moses, Dds, Ltd. | 05/12/2010SE |
| K090436 | Airwayease MasLRK · Traditional | Orthoplant Dental Lab | 04/16/2010SE |
| K092942 | Vital SleepLRK · Traditional | The Snore Reliever Company, LLC | 01/13/2010SE |
| K082849 | Silent SleepLRK · Abbreviated | Craniofacial Pain Center of Idaho | 07/16/2009SE |
| K090503 | Zquiet MouthpieceLRK · Traditional | Sleeping Well, LLC | 03/10/2009SE |
| K083209 | Acrylic Herbst Splint ApplianceLRK · Abbreviated | Specialty Appliance Works, Inc. | 01/27/2009SE |
| K081965 | Mpowrx Snoring SolutionLRK · Traditional | Mpowrx Health and Wellness Products, Inc. | 10/27/2008SE |
| K072731 | EndsnorLRK · Abbreviated | Dockstader Orthodontic Lab, Inc. | 06/12/2008SE |
| K073004 | Somnomed BflexLRK · Traditional | Somnomed, Inc. | 01/30/2008SE |
| K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch SnorinatorLRK · Traditional | Sybron Dental Specialties, Inc. | 05/25/2007SE |
| K060795 | SomnofitLRK · Abbreviated | Strategic Counsel Sarl | 12/18/2006SE |
| K062333 | LaimadLRK · Abbreviated | Steven Lamberg, D.D.S | 12/14/2006SE |
| K062951 | Tap III Anti-Snoring DeviceLRK · Traditional | Airway Management, Inc. | 12/12/2006SE |
| K061688 | Anti-Snoring / Sleep Apnea DeviceLRK · Traditional | Tomed Dr. Toussaint GmbH | 09/08/2006SE |
| K061732 | Tap-TLRK · Special | Airway Management, Inc. | 07/12/2006SE |
| K060744 | O'Brien Mpa (Mandibular Positioning Applicance)LRK · Abbreviated | O'Brien Dental Lab, Inc. | 06/02/2006SE |
| K060122 | Sleep SplintLRK · Traditional | Nakagawa Dental Clinic | 05/19/2006SE |
| K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentLRK · Traditional | Airway Management, Inc. | 05/17/2006SE |
| K051014 | Silent Partner Series Osa AppliancesLRK · Abbreviated | Dreamwrx Dental Laboratory | 08/09/2005SE |
| K050592 | Somnomed Mas RxaLRK · Traditional | Somnomed, Ltd. | 07/12/2005SE |
| K041184 | Nti Tension Suppression System, with a Snorehook ApplicationLRK · Traditional | Nti-Tss, Inc. | 05/03/2005SE |
| K042161 | Anti-Snoring/Sleep Apnea DeviceLRK · Traditional | Rj & VK Bird Pty , Ltd. | 10/27/2004SE |
| K040417 | Pillar Palatal Implant SystemLRK · Traditional | Restore Medical, Inc. | 07/28/2004SE |
| K021569 | Restful Nights, Ist-ApplianceLRK · Traditional | Ottawa Dental Laboratory | 03/15/2004SE |
| K033823 | Respironics Custom II Oral ApplianceLRK · Special | Respironics, Inc. | 02/06/2004SE |
| K033822 | Respironics Custom I Oral ApplianceLRK · Special | Respironics, Inc. | 02/06/2004SE |
| K030440 | Oasys-Oral Airway SystemLRK · Abbreviated | Mark Abramson, D.D.S., Inc. | 08/26/2003SE |
| K023836 | The Suad DeviceLRK · Abbreviated | Strong Dental, Inc. | 07/08/2003SE |
| K022891 | The Breathe Ez Anti-Snoring DeviceLRK · Traditional | D&S Redhage | 02/19/2003SE |
| K011723 | Anti-Snoring Device or AsdLRK · Traditional | Pi Medical | 12/18/2002SE |
| K022284 | Snore-Aid MaxLRK · Traditional | Dental Imagineers, LLC | 12/10/2002SE |
| K020893 | Norad Nocturnal Oral Airway Dilator ApplianceLRK · Traditional | Dennis R. Bailey, Dds | 05/28/2002SE |
| K013687 | Nose Breathe Mouthpiece for Heavy SnorerLRK · Traditional | Steven K. Sue | 05/28/2002SE |
| K013808 | SleepbiteLRK · Traditional | Dental Imagineers, LLC | 01/30/2002SE |
| K013049 | Norad, Nocturnal Oral Airway Dilator ApplianceLRK · Traditional | Dennis R. Bailey, Dds | 11/29/2001SE |
| K012142 | The Quiet SleeperLRK · Traditional | Precision Dental Laboratories, Inc. | 10/04/2001SE |
| K993381 | Tongue Stabilizer DeviceLRK · Traditional | University of Otago | 12/21/1999SE |
| K991209 | Oral Sleep Disorder AidLRK · Traditional | Perl-Rad Sleep Disorder Lab | 09/22/1999SE |
| K991948 | Dr. B'S Mouthpiece, Model 32129-10002LRK · Traditional | Snore - Ezzer | 09/02/1999SE |
| K981677 | Repose Bone Screw SystemLRK · Traditional | Influence, Inc. | 08/27/1999SE |
| K991449 | Snore-Aid PlusLRK · Traditional | Dental Imagineers, LLC | 07/22/1999SE |
| K981923 | The Snore PeaceLRK · Traditional | The Snore Peace Group | 08/24/1998SE |
| K980952 | Snore-Cure Anti-Snoring ApplianceLRK · Traditional | ORTHO-TAIN, Inc. | 06/01/1998SE |
| K974531 | Snore-EzzerLRK · Traditional | Snore - Ezzer | 02/12/1998SE |
| K973884 | Elastic Mandibular Advancement - Titration (Ema-T) AppilanceLRK · Traditional | Frantz Design, Inc. | 01/09/1998SE |
| K963591 | Snoring Control DeviceLRK · Traditional | Kenneth Hilsen | 01/09/1998SE |
| K973038 | Adjustable TherasnoreLRK · Traditional | Distar, Inc. | 11/12/1997SE |
| K971794 | Elastic Mandibular Advancement (Ema) ApplianceLRK · Traditional | Frantz Design, Inc. | 09/29/1997SE |
| K972424 | SilentniteLRK · Traditional | Glidewell Laboratories | 09/18/1997SE |
| K972023 | Sleep-In Bone Screw SystemLRK · Traditional | Influence, Inc. | 08/25/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2769-2026 Class II | Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number:…Due to device not having FDA Clearance | Prismatik Dentalcraft, Inc. | 04/27/2026Open, Classified |
| Z-0956-2026 Class II | Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc…Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. | Myofunctional Research Company USA | 10/09/2025Open, Classified |
| Z-1494-2022 Class II | CustMbite, Model Number CBT-SRS-ULThe device was marketed and sold in the US without FDA clearance. | Dental Choice Holding Llc | 05/23/2022Open, Classified |
| Z-1951-2018 Class II | Respire Pink H/S Oral Sleep Apnea DevicePotential for device breakage during use | Respire Medical | 09/01/2017Terminated |
| Z-1950-2018 Class II | Respire Pink H/S Oral Sleep Apnea DevicePotential for device breakage during use | Respire Medical | 09/01/2017Terminated |
| Z-1949-2018 Class II | Respire Pink+ Hard Oral Sleep Apnea DevicePotential for device breakage during use | Respire Medical | 09/01/2017Terminated |
| Z-1948-2018 Class II | Respire Pink+ Hard/Soft Oral Sleep Apnea DevicePotential for device breakage during use | Respire Medical | 09/01/2017Terminated |
| Z-1947-2018 Class II | Respire Pink Series EF+ Oral Sleep Apnea Device.Potential for device breakage during use | Respire Medical | 09/01/2017Terminated |
| Z-0536-2010 | Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic…Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to… | Medtronic Xomed, Inc. | 07/27/2009Terminated |
| Z-0535-2010 | Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by…Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to… | Medtronic Xomed, Inc. | 07/27/2009Terminated |