FDA 510(k) Applications for Medical Device Product Code "LRK"
(Device, Anti-Snoring)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K111110 | ADVANCED BRAIN MONITORING, INC. | APNEA GUARD | 07/22/2011 |
| K060388 | AIRWAY MANAGEMENT INC. | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT | 05/17/2006 |
| K062951 | AIRWAY MANAGEMENT INC. | TAP III ANTI-SNORING DEVICE | 12/12/2006 |
| K061732 | AIRWAY MANAGEMENT INC. | TAP-T | 07/12/2006 |
| K181482 | Airway Management, Inc. | myTAP2 | 08/31/2018 |
| K160123 | Allen J. Moses, DDS LTD | Apinator | 07/12/2016 |
| K093710 | ALLEN J. MOSES, DDS, LTD. | THE MOSES APPLIANCE | 05/12/2010 |
| K132933 | ALLEN J. MOSES, DDS, LTD. | THE MOSES ELITE APPLIANCE | 04/25/2014 |
| K142651 | ALLEN J. MOSES, DDS, LTD. | The Moses Express appliance | 07/17/2015 |
| K182312 | Always More Marketing | Zyppah Anti-Snoring Device | 01/24/2019 |
| K120371 | ALWAYS MORE MARKETING INC | DR GREENBURGS HYBRID ACRYLIC | 06/27/2012 |
| K120372 | ALWAYS MORE MARKETING INC | DR GREENBURGS HYBRID VACUUM | 06/27/2012 |
| K111680 | ALWAYS MORE MARKETING INC | DR. GREENSBURG'S HYBRID | 12/23/2011 |
| K140435 | AMERICAN DENTAL SLEEP MEDICINE, IP, LLC | MEDLEY GOLD | 06/26/2014 |
| K130504 | AMERICAN SLEEP ASSOCIATION | ASA ORAL APPLIANCES | 10/18/2013 |
| K163580 | AMERICAN SLEEP DENTISTRY | ASD Oral Appliances | 06/08/2017 |
| K113569 | APNEA SCIENCE CORPORATION | APNEARX | 03/01/2012 |
| K223901 | Apnea Sciences Coporation | ApneaRX Pro | 09/01/2023 |
| K153200 | Apnea Sciences Corporation | SnoreRx | 08/09/2016 |
| K170825 | Apnea Sciences Corporation | SnoreRx | 08/18/2017 |
| K181123 | ApnoMed, Inc. | ApnoDent Appliance | 11/21/2018 |
| K173064 | B. Fareid, DDS, PC | ZAPnea Oral Appliance | 03/08/2019 |
| K130067 | BIOMODELING SOLUTIONS, LLS | MRNA APPLIANCE | 05/08/2014 |
| K162192 | BlueSom | BluePro | 12/15/2016 |
| K182202 | Comfort Acrylics, Inc. | SLEEPAPP | 01/11/2019 |
| K112205 | CONSUMER HEALTH PRODUCTS, INC | SNORERX 9.0 | 11/16/2011 |
| K181416 | Crane Dental Laboratory, Inc | Sapphire Dorsal Comfort Fit | 09/17/2019 |
| K140429 | CRANE DENTAL LABORATORY, INC. | CRANE ACRYLIC HERBST APPLIANCE | 09/11/2014 |
| K082849 | CRANIOFACIAL PAIN CENTER OF IDAHO | SILENT SLEEP | 07/16/2009 |
| K022891 | D&S REDHAGE | THE BREATHE EZ ANTI-SNORING DEVICE | 02/19/2003 |
| K203462 | DaSoft Partners | Advanced Dental Appliance | 02/19/2021 |
| K172991 | DaSoft Partners | Advanced Dental Applicance | 07/10/2018 |
| K020893 | DENNIS R. BAILEY, DDS | NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | 05/28/2002 |
| K013049 | DENNIS R. BAILEY, DDS | NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | 11/29/2001 |
| K221322 | Dental Choice Holdings LLC | CUSTMBITE Snoring System | 10/27/2022 |
| K022284 | DENTAL IMAGINEERS, LLC | SNORE-AID MAX | 12/10/2002 |
| K013808 | DENTAL IMAGINEERS, LLC. | SLEEPBITE | 01/30/2002 |
| K991449 | DENTAL IMAGINEERS, LLC. | SNORE-AID PLUS | 07/22/1999 |
| K202499 | Diamond Orthotic Laboratory | Diamond Digital Sleep Orthotic (DDSO) | 09/03/2020 |
| K973038 | DISTAR, INC. | ADJUSTABLE THERASNORE | 11/12/1997 |
| K140663 | DISTAR, LLC | THERASNORE | 12/12/2014 |
| K072731 | DOCKSTADER ORTHODONTIC LAB, INC. | ENDSNOR | 06/12/2008 |
| K051014 | DREAMWRX DENTAL LABORATORY | SILENT PARTNER SERIES OSA APPLIANCES | 08/09/2005 |
| K103076 | DYNAFLEX | DYNAFLEX | 02/23/2011 |
| K232735 | EMA Sleep Incorporated | EMA 3D | 05/03/2024 |
| K111009 | EMBASSY DENTAL LABORATORY | ACRYLIC HERBST APPLIANCE | 07/22/2011 |
| K093340 | EXACT SUPPLIES LTD. | PASR/QUIETNITE | 06/11/2010 |
| K113516 | FAMILY DENTAL SERVICES, P.C. | THERASOM-CAST | 01/04/2013 |
| K160531 | FIRMA INGEMARSSON | Noiselezz | 09/01/2016 |
| K250482 | Fissiontech LLC | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | 05/08/2025 |
| K233850 | Fissiontech LLC | Difiney Anti Snoring Device | 04/18/2024 |
| K973884 | FRANTZ DESIGN, INC. | ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE | 01/09/1998 |
| K971794 | FRANTZ DESIGN, INC. | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | 09/29/1997 |
| K161980 | FUSELIER ENTERPRISES, LLC | Fuselier Intraoral Nighttime Device (FIND) | 02/07/2017 |
| K240427 | Gelb Practice Solutions, Inc. | airVataÖ | 02/14/2024 |
| K113126 | GERGENS ORTHODONTIC LAB | ACRYLIC HERBST APPLIANCE | 07/17/2013 |
| K143591 | GERGENS ORTHODONTIC LAB | Dorsal Appliance | 04/15/2015 |
| K972424 | GLIDEWELL LABORATORIES | SILENTNITE | 09/18/1997 |
| K232025 | Good Sleep Co Pte Ltd. | Hushd Pro Avera | 05/09/2024 |
| K220330 | Greystone IP Ltd | Soundly Anti Snoring Device | 09/08/2022 |
| K123410 | HEALTHY SLEEP DENTAL LABORATORY | HEALTHY SLEEP APPLIANCE | 04/05/2013 |
| K981677 | INFLUENCE, INC. | REPOSE BONE SCREW SYSTEM | 08/27/1999 |
| K972023 | INFLUENCE, INC. | SLEEP-IN BONE SCREW SYSTEM | 08/25/1997 |
| K231663 | Innovative Health Technologies (NZ), Ltd | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | 09/18/2023 |
| K172760 | Insert Molding Solutions, Inc. | REST EAZY Appliance | 03/26/2018 |
| K133390 | INSTITUTE FOR QUALITY RESOURCE MANAGEMENT | NDX DORSAL APPLIANCE | 10/16/2014 |
| K223624 | Island Dental Lab, Inc dba Emerald Dental | Emerald Herbst | 05/10/2023 |
| K963591 | KENNETH HILSEN | SNORING CONTROL DEVICE | 01/09/1998 |
| K201484 | Koncept Innovators, LLC. | Somnos Anti-Snoring Mouth Guard | 11/23/2020 |
| K102463 | LARRY V CONNELL, DMD | GOOD NIGHT | 05/25/2011 |
| K130797 | LUCO HYBRID OSA APPLIANCE INC. | LUCO HYBRID OSA APPLIANCE | 12/18/2013 |
| K030440 | MARK ABRAMSON, D.D.S., INC | OASYS-ORAL AIRWAY SYSTEM | 08/26/2003 |
| K963063 | MARKETING TECHNOLOGIES, INC. | SNORE TEC | 04/14/1997 |
| K122391 | MEDTRONIC XOMED, INC. | MEDTRONIC XOMED, INC. | 01/10/2013 |
| K110623 | MEDTRONIC XOMED, INC. | PILLAR PALATAL IMPLANT SYSTEM | 02/10/2012 |
| K203606 | Meris Investment Group | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | 03/10/2021 |
| K191618 | Michael D Williams DDS PA | SleepTight Mouthpiece STZ | 12/11/2019 |
| K132506 | MICHAEL D. WILLIAMS,DDS PA | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY | 05/29/2014 |
| K133683 | MICRODENTAL, INC. | MICR02 OSA DEVICE | 07/24/2014 |
| K173856 | Moses Appliances LLC | Express 4 Sleep appliance/CPAP Sidekick appliance | 06/26/2018 |
| K193239 | MPowRx Health and Wellness Products 2012 Inc | MPowRx Snoring Solution (also known as Good Morning Snore Solution) | 01/03/2020 |
| K081965 | MPOWRX HEALTH AND WELLNESS PRODUCTS INC. | MPOWRX SNORING SOLUTION | 10/27/2008 |
| K060122 | NAKAGAWA DENTAL CLINIC | SLEEP SPLINT | 05/19/2006 |
| K964516 | NELLCOR PURITAN BENNETT, INC. | TAP | 01/24/1997 |
| K962516 | NELLCOR PURITAN BENNETT, INC. | TAP ANTI-SNORING DEVICE | 09/10/1996 |
| K121285 | NEW JERSEY SNORING SOLUTIONS | ORAVAN OSA | 03/08/2013 |
| K041184 | NTI-TSS, INC. | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION | 05/03/2005 |
| K060744 | O'BRIEN DENTAL LAB, INC. | O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) | 06/02/2006 |
| K152159 | OravanOSA, LLC | Oravan Herbst | 10/29/2015 |
| K980952 | ORTHO-TAIN, INC. | SNORE-CURE ANTI-SNORING APPLIANCE | 06/01/1998 |
| K203477 | Orthoapnea S.L. | Classic | 02/25/2021 |
| K202651 | Orthoapnea S.L. | NOA Sleep Apnea and Snoring Device | 02/12/2021 |
| K090436 | ORTHOPLANT DENTAL LAB | AIRWAYEASE MAS | 04/16/2010 |
| K231138 | Oscimed SA | Aniti-Snore Mouthguard+ | 01/16/2024 |
| K021569 | OTTAWA DENTAL LABORATORY | RESTFUL NIGHTS, IST-APPLIANCE | 03/15/2004 |
| K190236 | Oventus Manufacturing PTY LTD | O2Vent Optima | 08/29/2019 |
| K161832 | OVENTUS MANUFACTURING PTY LTD | O2VENT T | 09/23/2016 |
| K171316 | Oventus Manufacturing Pty Ltd | O2Vent W | 07/11/2017 |
| K160234 | OVENTUS MANUFACTURING PTY LTD | OVENT | 03/17/2016 |
| K143244 | Panthera Dental Inc. | The Panthera Anti-Snoring Device | 12/15/2014 |
| K171576 | Panthera Dental Inc. | The Panthera Anti-Snoring X3 Device | 02/22/2018 |
| K181396 | Passion for Life Healthcare (UK) Limited | Oral Device OA, Oral Device S | 11/16/2018 |
| K991209 | PERL-RAD SLEEP DISORDER LAB | ORAL SLEEP DISORDER AID | 09/22/1999 |
| K011723 | PI MEDICAL | ANTI-SNORING DEVICE OR ASD | 12/18/2002 |
| K012142 | PRECISION DENTAL LABORATORIES, INC. | THE QUIET SLEEPER | 10/04/2001 |
| K233434 | Prismatik Dentalcraft, Inc | Silent Nite« Sleep Appliance with the Glidewell HingeÖ (SNGLHG) | 11/14/2023 |
| K211069 | Prismatik Dentalcraft, Inc. | EndSnorZ Sleep Appliance | 10/26/2021 |
| K183270 | Prismatik Dentalcraft, Inc. | Silent Nite sl | 07/17/2019 |
| K210694 | Prismatik Dentalcraft, Inc. | Silent Nite Sleep Appliance with the Glidewell Hinge | 06/16/2021 |
| K221889 | ProSomnus Sleep Technologies | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | 10/06/2022 |
| K202529 | ProSomnus Sleep Technologies, Inc. | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | 11/20/2020 |
| K103004 | RANIR LLC | SNORE GUARD | 02/25/2011 |
| K102118 | RANIR LLC | SNORE GUARD ADVANCE | 09/08/2010 |
| K111207 | RESPIRE MEDICAL | RESPIRE BLUE SERIES | 08/23/2011 |
| K131138 | RESPIRE MEDICAL | RESPIRE PINK SERIES - HERBST | 09/09/2013 |
| K152292 | Respire Medical Holding | Respire Blue Series-EF | 12/07/2015 |
| K170692 | Respire Medical Holding | Respire Pink Series with DentiTrac | 05/26/2017 |
| K150572 | Respire Medical Holding | Respire Pink Series-Herbst-EF | 08/27/2015 |
| K192127 | Respire Medical Holdings | Respire Pink AT (Hard, Hard/Soft, EF) | 02/05/2020 |
| K214096 | Respire Medical, LLC | Respire Clear | 05/31/2022 |
| K033822 | RESPIRONICS, INC. | RESPIRONICS CUSTOM I ORAL APPLIANCE | 02/06/2004 |
| K033823 | RESPIRONICS, INC. | RESPIRONICS CUSTOM II ORAL APPLIANCE | 02/06/2004 |
| K040417 | RESTORE MEDICAL INC. | PILLAR PALATAL IMPLANT SYSTEM | 07/28/2004 |
| K121344 | RH ASSOCIATES LLC | NU SLEEP | 10/17/2012 |
| K042161 | RJ & VK BIRD PTY LTD. | ANTI-SNORING/SLEEP APNEA DEVICE | 10/27/2004 |
| K210636 | S4S UK Ltd. | Morpheus | 02/15/2022 |
| K150566 | SAS Oniris | Oniris | 03/21/2016 |
| K171529 | Scope Healthcare Technologies Pty Ltd | Snorer's Friend | 01/02/2018 |
| K955336 | SCOTT FELDMAN DDS & NORMAN SHAPIRO DDS | SNOREFREE | 01/04/1996 |
| K220688 | Shinrin-Yoku Traders LLC | SilentZPro 2.0 | 12/02/2022 |
| K153291 | SICAT GMBH & CO. KG | SICAT OPTISLEEP | 03/31/2016 |
| K182661 | Sketchpad Innovations LLC | Kava and Kava with Herbst | 02/13/2019 |
| K100185 | SLEEP MEDICINE NETWORK, INC. | SLEEP APP | 11/19/2010 |
| K113022 | SLEEP SCIENCE PARTNERS, INC. | PURESLEEP | 06/11/2012 |
| K190058 | Sleep Science Partners, Inc. | PureSleep (OTC use) | 04/11/2019 |
| K213088 | Sleeping Well, LLC | ZQuiet Advance | 06/15/2022 |
| K090503 | SLEEPING WELL, LLC | ZQUIET MOUTHPIECE | 03/10/2009 |
| K093407 | SLEEPING WELL, LLC | ZQUIET MOUTHPIECE | 06/22/2010 |
| K122475 | SLEEPING WELL, LLC | ZQUIET PRO-PLUS | 12/07/2012 |
| K140777 | SLEEPING WELL, LLC | ZQUIET-SA | 07/25/2014 |
| K180124 | Sleeping Well,LLC | ZQuiet | 06/12/2018 |
| K101155 | SLEEPWRIGHT | AURADORM (NEUROMUSCULAR SLEEP) | 05/12/2011 |
| K200657 | SmartGuard Rx Inc. | SmartGuard Anti-Snoring Device | 08/23/2021 |
| K991948 | SNORE - EZZER | DR. B'S MOUTHPIECE, MODEL 32129-10002 | 09/02/1999 |
| K974531 | SNORE - EZZER | SNORE-EZZER | 02/12/1998 |
| K210910 | SnoreBandit LLC | Snore Bandit | 07/01/2021 |
| K222475 | Solbaro Co., Ltd | SNOR LOCK | 11/10/2022 |
| K152660 | Somnics Inc. | HYPNOSPAD | 11/09/2016 |
| K102521 | SOMNOMED INC. | PANTINO PRO POSITINER | 03/28/2011 |
| K162306 | SomnoMed Inc. | SomnoDent ALPHA | 09/20/2016 |
| K183443 | SomnoMed Inc. | SomnoDent Avant | 05/08/2019 |
| K140278 | SOMNOMED INC. | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | 06/20/2014 |
| K121340 | SOMNOMED INC. | SOMNODENT G2 | 05/30/2012 |
| K130558 | SOMNOMED INC. | SOMNODENT HERBST; CLASSIC, FLEX | 05/17/2013 |
| K073004 | SOMNOMED INC. | SOMNOMED BFLEX | 01/30/2008 |
| K050592 | SOMNOMED LTD | SOMNOMED MAS RXA | 07/12/2005 |
| K150941 | Somnowell Ltd. | Somnowell Mandibular Advancement Appliance (MAA) | 05/22/2015 |
| K083209 | SPECIALTY APPLIANCE WORKS, INC. | ACRYLIC HERBST SPLINT APPLIANCE | 01/27/2009 |
| K250122 | Splintek Inc. | SleepRight Snore Aid | 05/19/2025 |
| K190687 | Stephen J Harkins, DDS, PC | Twilite Appliance | 07/02/2019 |
| K101709 | STEVEN B. LAMBERG, DDS | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) | 08/18/2010 |
| K013687 | STEVEN K. SUE | NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER | 05/28/2002 |
| K062333 | STEVEN LAMBERG, D.D.S | LAIMAD | 12/14/2006 |
| K060795 | STRATEGIC COUNSEL SARL | SOMNOFIT | 12/18/2006 |
| K023836 | STRONG DENTAL INC. | THE SUAD DEVICE | 07/08/2003 |
| K070327 | SYBRON DENTAL SPECIALTIES, INC. | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | 05/25/2007 |
| K170053 | The Center for Craniofacial & Dental Sleep Medicine | Meridian PM | 11/28/2017 |
| K981923 | THE SNORE PEACE GROUP | THE SNORE PEACE | 08/24/1998 |
| K092942 | THE SNORE RELIEVER COMPANY LLC | VITAL SLEEP | 01/13/2010 |
| K201719 | The Snore Reliever Company, LLC | Vital Sleep | 01/14/2021 |
| K222127 | The TMJ Clinic, PC. | Soft Palate Elevator | 10/24/2022 |
| K061688 | TOMED DR. TOUSSAINT GMBH | ANTI-SNORING / SLEEP APNEA DEVICE | 09/08/2006 |
| K121761 | TOMED DR. TOUSSAINT GMBH | SOMNOGUARD SP SOFT | 09/28/2012 |
| K170578 | True Function Laboratory, Inc. | True Function Adjustable Herbst Appliances | 11/24/2017 |
| K180691 | True Function Laboratory, Inc. | TrueDorsal Devices | 02/11/2019 |
| K955822 | UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS | REMOVABLE HERBST APPLIANCE | 03/20/1996 |
| K993381 | UNIVERSITY OF OTAGO | TONGUE STABILIZER DEVICE | 12/21/1999 |
| K234089 | Vivos Therapeutics | DNA Appliance | 09/16/2024 |
| K230947 | Vivos Therapeutics, Inc | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | 11/28/2023 |
| K222872 | Vivos Therapeutics, Inc. | DNA Appliance | 12/30/2022 |
| K210203 | Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) | mmRNA appliance | 08/19/2021 |
| K972061 | W. KEITH THORNTON, D.D.S. | TOA | 08/21/1997 |
| K213475 | Zelegent, Inc. | Elevo Snoring Intervention Set | 01/27/2022 |
| K181107 | Zelegent, Inc. | Elevo« Kit Snoring Intervention Device | 12/06/2018 |
| K103704 | ZEPHYR SLEEP TECHNOLOGIES INC | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP | 03/23/2012 |
| K190051 | Zephyr Sleep Technologies, Inc. | TD Clip | 06/07/2019 |
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