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FDA clearance lookup: anti-snoring and sleep appliances
Search all 254 FDA 510(k) clearances under the three sleep-appliance product codes.
Source: FDA 510(k) premarket notification database via openFDA. Retrieved (FDA data last updated November 2, 2026).
254 of 254 records
| 510(k) | Device name (as filed) | Applicant | Decision date | Code |
|---|---|---|---|---|
| K262937 | PDR Airway Device | Park Dental Research Corp. | 2026-10-20 | LRK |
| K260136 | Forza | True Function Laboratory, Inc. | 2026-10-06 | LRK |
| 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 | LRK |
| K254304 | iNOS intraoral biosensor | Achaemenid, LLC | 2026-08-25 | PLC |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026-07-31 | LRK |
| K261366 | VirtusBrand page | Somnomed, Inc. | 2026-06-12 | LRK |
| K261251 | Snorbliss® Anti-Snoring DeviceBrand page | Endeavor Commerce, LLC | 2026-06-11 | LRK |
| K261134 | Dormiva Anti-Snoring Mouth GuardBrand page | Koncept Innovators, Inc. | 2026-05-14 | LRK |
| K252942 | ShaeferH | Shaeferh, LLC | 2026-04-10 | LRK |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA)Brand page | Prosomnus Sleep Technologies | 2026-04-06 | PLC |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | 2026-03-03 | LRK |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Brand page | Myofunctional Research Co. | 2026-03-02 | LRK |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 | LRK |
| K253868 | QuietLab Pro | QuietLab, LLC | 2025-12-05 | LRK |
| K252161 | Hushd AveraBrand page | Good Sleep CO Pte , Ltd. | 2025-11-25 | LRK |
| K252525 | AIO Breathe | Aiomega, LLC | 2025-11-06 | LRK |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025-11-03 | LRK |
| K253355 | Difiney Advanced Anti Snoring Device 4.0Brand page | Fissiontech, LLC | 2025-10-29 | LRK |
| K251784 | Hushd Pro Z-LinkBrand page | Good Sleep CO Pte , Ltd. | 2025-10-24 | LRK |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025-10-22 | LRK |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 | LRK |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | 2025-09-17 | LRK |
| K252374 | Nylon flexTAP(R)Brand page | Airway Technologies D/B/A Airway Management | 2025-09-11 | LRK |
| K250353 | Oniris; Oniris Plus | Oniris | 2025-09-04 | LRK |
| K250122 | SleepRight Snore AidBrand page | Splintek, Inc. | 2025-05-19 | LRK |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueBrand page | Fissiontech, LLC | 2025-05-08 | LRK |
| K233497 | Rest Assure SystemBrand page | Somnomed, Inc. | 2024-10-03 | PLC |
| K234089 | DNA ApplianceBrand page | Vivos Therapeutics | 2024-09-16 | LRK |
| K232025 | Hushd Pro AveraBrand page | Good Sleep CO Pte , Ltd. | 2024-05-09 | LRK |
| K232735 | EMA 3DBrand page | Ema Sleep Incorporated | 2024-05-03 | LRK |
| K233850 | Difiney Anti Snoring DeviceBrand page | Fissiontech, LLC | 2024-04-18 | LRK |
| K233754 | AIO Breathe | Aiomega, LLC | 2024-02-23 | LQZ |
| K240427 | airVata™ | Gelb Practice Solutions, Inc. | 2024-02-14 | LRK |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | 2024-01-16 | LRK |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA)Brand page | Vivos Therapeutics, Inc. | 2023-11-28 | LRK |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Brand page | Prismatik Dentalcraft, Inc. | 2023-11-14 | LRK |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) MouthpieceBrand page | Innovative Health Technologies (Nz), Ltd. | 2023-09-18 | LRK |
| K223901 | ApneaRX ProBrand page | Apnea Sciences Coporation | 2023-09-01 | LRK |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | 2023-07-12 | LQZ |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023-05-10 | LRK |
| K222872 | DNA ApplianceBrand page | Vivos Therapeutics, Inc. | 2022-12-30 | LRK |
| K220688 | SilentZPro 2.0Brand page | Shinrin-Yoku Traders, LLC | 2022-12-02 | LRK |
| K222475 | SNOR LOCK | Solbaro Co., Ltd. | 2022-11-10 | LRK |
| K221322 | CUSTMBITE Snoring System | Dental Choice Holdings, LLC | 2022-10-27 | LRK |
| K222127 | Soft Palate Elevator | The Tmj Clinic PC | 2022-10-24 | LRK |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringBrand page | Prosomnus Sleep Technologies | 2022-10-06 | LRK |
| K220330 | Soundly Anti Snoring DeviceBrand page | Greystone Ip, Ltd. | 2022-09-08 | LRK |
| K213088 | ZQuiet AdvanceBrand page | Sleeping Well, LLC | 2022-06-15 | LRK |
| K214096 | Respire Clear | Respire Medical, LLC | 2022-05-31 | LRK |
| K210636 | Morpheus | S4S UK , Ltd. | 2022-02-15 | LRK |
| K213475 | Elevo Snoring Intervention SetBrand page | Zelegent, Inc. | 2022-01-27 | LRK |
| K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | 2021-10-26 | LRK |
| K200657 | SmartGuard Anti-Snoring DeviceBrand page | Smartguard Rx, Inc. | 2021-08-23 | LRK |
| K210203 | mmRNA applianceBrand page | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | 2021-08-19 | LRK |
| K203712 | The Slide | Biotex, Inc. | 2021-07-20 | LQZ |
| K210910 | Snore BanditBrand page | Snorebandit, LLC | 2021-07-01 | LRK |
| K210694 | Silent Nite Sleep Appliance with the Glidewell HingeBrand page | Prismatik Dentalcraft, Inc. | 2021-06-16 | LRK |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Meris Investment Group | 2021-03-10 | LRK |
| K203477 | Classic | Orthoapnea S.L. | 2021-02-25 | LRK |
| K203462 | Advanced Dental Appliance | Dasoft Partners | 2021-02-19 | LRK |
| K202651 | NOA Sleep Apnea and Snoring Device | Orthoapnea S.L. | 2021-02-12 | LRK |
| K201719 | Vital SleepBrand page | The Snore Reliever Company, LLC | 2021-01-14 | LRK |
| K201484 | Somnos Anti-Snoring Mouth GuardBrand page | Koncept Innovators, LLC | 2020-11-23 | LRK |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringBrand page | Prosomnus Sleep Technologies, Inc. | 2020-11-20 | LRK |
| K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020-10-02 | LQZ |
| K202499 | Diamond Digital Sleep Orthotic (DDSO) | Diamond Orthotic Laboratory | 2020-09-03 | LRK |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020-04-10 | PLC |
| K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | 2020-02-05 | LRK |
| K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020-01-28 | LQZ |
| K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution)Brand page | Mpowrx Health and Wellness Products 2012, Inc. | 2020-01-03 | LRK |
| K191618 | SleepTight Mouthpiece STZBrand page | Michael D Williams Dds PA | 2019-12-11 | LRK |
| K181416 | Sapphire Dorsal Comfort Fit | Crane Dental Laboratory, Inc. | 2019-09-17 | LRK |
| K190236 | O2Vent OptimaBrand page | Oventus Manufacturing Pty, Ltd. | 2019-08-29 | LRK |
| K183270 | Silent Nite slBrand page | Prismatik Dentalcraft, Inc. | 2019-07-17 | LRK |
| K190687 | Twilite Appliance | Stephen J Harkins, Dds, PC | 2019-07-02 | LRK |
| K190051 | TD Clip | Zephyr Sleep Technologies, Inc. | 2019-06-07 | LRK |
| K183443 | SomnoDent AvantBrand page | Somnomed, Inc. | 2019-05-08 | LRK |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | 2019-04-19 | PLC |
| K190058 | PureSleep (OTC use)Brand page | Sleep Science Partners, Inc. | 2019-04-11 | LRK |
| K173064 | ZAPnea Oral Appliance | B. Fareid, Dds, PC | 2019-03-08 | LRK |
| K182661 | Kava and Kava with Herbst | Sketchpad Innovations, LLC | 2019-02-13 | LRK |
| K180691 | TrueDorsal Devices | True Function Laboratory, Inc. | 2019-02-11 | LRK |
| K182312 | Zyppah Anti-Snoring DeviceBrand page | Always More Marketing | 2019-01-24 | LRK |
| K182202 | SLEEPAPP | Comfort Acrylics, Inc. | 2019-01-11 | LRK |
| K181107 | Elevo® Kit Snoring Intervention DeviceBrand page | Zelegent, Inc. | 2018-12-06 | LRK |
| K181123 | ApnoDent Appliance | Apnomed, Inc. | 2018-11-21 | LRK |
| K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | 2018-11-16 | LRK |
| K181482 | myTAP2Brand page | Airway Management, Inc. | 2018-08-31 | LRK |
| K172991 | Advanced Dental Applicance | Dasoft Partners | 2018-07-10 | LRK |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance | Moses Appliances, LLC | 2018-06-26 | LRK |
| K180124 | ZQuietBrand page | Sleeping Well, LLC | 2018-06-12 | LRK |
| K172760 | REST EAZY Appliance | Insert Molding Solutions, Inc. | 2018-03-26 | LRK |
| K171576 | The Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. | 2018-02-22 | LRK |
| K171529 | Snorer's Friend | Scope Healthcare Technologies Pty, Ltd. | 2018-01-02 | LRK |
| K170053 | Meridian PM | The Center For Craniofacial & Dental Sleep Medicine | 2017-11-28 | LRK |
| K170578 | True Function Adjustable Herbst Appliances | True Function Laboratory, Inc. | 2017-11-24 | LRK |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | 2017-11-22 | PLC |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | 2017-11-16 | PLC |
| K170825 | SnoreRxBrand page | Apnea Sciences Corporation | 2017-08-18 | LRK |
| K162816 | SML-OSA2 Appliances | Selane Products, Inc. | 2017-07-27 | LQZ |
| K171316 | O2Vent WBrand page | Oventus Manufacturing Pty, Ltd. | 2017-07-11 | LRK |
| K163580 | ASD Oral Appliances | American Sleep Dentistry | 2017-06-08 | LRK |
| K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017-05-26 | LRK |
| K161980 | Fuselier Intraoral Nighttime Device (FIND) | Fuselier Enterprises, LLC | 2017-02-07 | LRK |
| K162192 | BluePro | Bluesom | 2016-12-15 | LRK |
| K152660 | HYPNOSPAD | Somnics, Inc. | 2016-11-09 | LRK |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016-11-07 | PLC |
| K161832 | O2VENT TBrand page | Oventus Manufacturing Pty, Ltd. | 2016-09-23 | LRK |
| K162306 | SomnoDent ALPHABrand page | Somnomed, Inc. | 2016-09-20 | LRK |
| K160531 | Noiselezz | Firma Ingemarsson | 2016-09-01 | LRK |
| K160239 | TAP 3, TAP 1Brand page | Airway Management, Inc. | 2016-08-10 | PLC |
| K153200 | SnoreRxBrand page | Apnea Sciences Corporation | 2016-08-09 | LRK |
| K160123 | Apinator | Allen J. Moses, Dds, Ltd. | 2016-07-12 | LRK |
| K153291 | SICAT OPTISLEEP | Sicat GmbH & Co. KG | 2016-03-31 | LRK |
| K150566 | Oniris | Sas Oniris | 2016-03-21 | LRK |
| K160234 | OVENTBrand page | Oventus Manufacturing Pty, Ltd. | 2016-03-17 | LRK |
| K152292 | Respire Blue Series-EF | Respire Medical Holding | 2015-12-07 | LRK |
| K152159 | Oravan Herbst | Oravanosa, LLC | 2015-10-29 | LRK |
| K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | 2015-08-27 | LRK |
| K142651 | The Moses Express appliance | Allen J. Moses, Dds, Ltd. | 2015-07-17 | LRK |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorderBrand page | Somnomed, Inc. | 2015-06-18 | PLC |
| K150941 | Somnowell Mandibular Advancement Appliance (MAA) | Somnowell , Ltd. | 2015-05-22 | LRK |
| K143591 | Dorsal Appliance | Gergens Orthodontic Lab | 2015-04-15 | LRK |
| K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014-12-15 | LRK |
| K140663 | THERASNORE | Distar, LLC | 2014-12-12 | LRK |
| K133390 | NDX DORSAL APPLIANCE | Institute For Quality Resource Management | 2014-10-16 | LRK |
| K140429 | CRANE ACRYLIC HERBST APPLIANCE | Crane Dental Laboratory, Inc. | 2014-09-11 | LRK |
| K140777 | ZQUIET-SABrand page | Sleeping Well, LLC | 2014-07-25 | LRK |
| K133683 | MICR02 OSA DEVICE | Microdental, Inc. | 2014-07-24 | LRK |
| K140435 | MEDLEY GOLD | American Dental Sleep Medicine, Ip, LLC | 2014-06-26 | LRK |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXBrand page | Somnomed, Inc. | 2014-06-20 | LRK |
| K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASYBrand page | Michael D Williams Dds PA | 2014-05-29 | LRK |
| K130067 | MRNA APPLIANCE | Biomodeling Solutions, Lls | 2014-05-08 | LRK |
| K132933 | THE MOSES ELITE APPLIANCE | Allen J. Moses, Dds, Ltd. | 2014-04-25 | LRK |
| K130797 | LUCO HYBRID OSA APPLIANCE | Luco Hybrid Osa Appliance, Inc. | 2013-12-18 | LRK |
| K130504 | ASA ORAL APPLIANCES | American Sleep Association | 2013-10-18 | LRK |
| K131138 | RESPIRE PINK SERIES - HERBST | Respire Medical | 2013-09-09 | LRK |
| K130130 | ATG/SM-OSA APPLIANCES | Selane Products, Inc. | 2013-08-26 | LQZ |
| K113126 | ACRYLIC HERBST APPLIANCE | Gergens Orthodontic Lab | 2013-07-17 | LRK |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEXBrand page | Somnomed, Inc. | 2013-05-17 | LRK |
| K123410 | HEALTHY SLEEP APPLIANCE | Healthy Sleep Dental Laboratory | 2013-04-05 | LRK |
| K121285 | ORAVAN OSA | New Jersey Snoring Solutions | 2013-03-08 | LRK |
| K122391 | MEDTRONIC XOMED, INC. | Medtronic Xomed, Inc. | 2013-01-10 | LRK |
| K113516 | THERASOM-CAST | Family Dental Services, P.C. | 2013-01-04 | LRK |
| K122475 | ZQUIET PRO-PLUSBrand page | Sleeping Well, LLC | 2012-12-07 | LRK |
| K121344 | NU SLEEP | Rh Associates, LLC | 2012-10-17 | LRK |
| K121761 | SOMNOGUARD SP SOFT | Tomed Dr. Toussaint GmbH | 2012-09-28 | LRK |
| K120372 | DR GREENBURGS HYBRID VACUUM | Always More Marketing, Inc. | 2012-06-27 | LRK |
| K120371 | DR GREENBURGS HYBRID ACRYLIC | Always More Marketing, Inc. | 2012-06-27 | LRK |
| K113022 | PURESLEEPBrand page | Sleep Science Partners, Inc. | 2012-06-11 | LRK |
| K112627 | MILLENIUM ANTI-SNORING DEVICE | Millenium Dental Laboratory, Inc. | 2012-06-06 | LQZ |
| K112766 | SNORKEL | Fellmar Company | 2012-06-04 | LQZ |
| K121340 | SOMNODENT G2Brand page | Somnomed, Inc. | 2012-05-30 | LRK |
| K103704 | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP | Zephyr Sleep Technologies, Inc. | 2012-03-23 | LRK |
| K113569 | APNEARXBrand page | Apnea Science Corporation | 2012-03-01 | LRK |
| K110623 | PILLAR PALATAL IMPLANT SYSTEM | Medtronic Xomed, Inc. | 2012-02-10 | LRK |
| K111680 | DR. GREENSBURG'S HYBRID | Always More Marketing, Inc. | 2011-12-23 | LRK |
| K113201 | NARVAL CCBrand page | Resmed Sas | 2011-12-01 | LQZ |
| K112205 | SNORERX 9.0Brand page | Consumer Health Products, Inc. | 2011-11-16 | LRK |
| K111207 | RESPIRE BLUE SERIES | Respire Medical | 2011-08-23 | LRK |
| K111009 | ACRYLIC HERBST APPLIANCE | Embassy Dental Laboratory | 2011-07-22 | LRK |
| K111110 | APNEA GUARD | Advanced Brain Monitoring, Inc. | 2011-07-22 | LRK |
| K102463 | GOOD NIGHT | Larry V Connell, Dmd | 2011-05-25 | LRK |
| K101155 | AURADORM (NEUROMUSCULAR SLEEP) | Sleepwright | 2011-05-12 | LRK |
| K102521 | PANTINO PRO POSITINERBrand page | Somnomed, Inc. | 2011-03-28 | LRK |
| K103004 | SNORE GUARDBrand page | Ranir, LLC | 2011-02-25 | LRK |
| K103076 | DYNAFLEX | Dyna Flex | 2011-02-23 | LRK |
| K100185 | SLEEP APP | Sleep Medicine Network, Inc. | 2010-11-19 | LRK |
| K102118 | SNORE GUARD ADVANCEBrand page | Ranir, LLC | 2010-09-08 | LRK |
| K101709 | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) | Steven B. Lamberg, Dds | 2010-08-18 | LRK |
| K093407 | ZQUIET MOUTHPIECEBrand page | Sleeping Well, LLC | 2010-06-22 | LRK |
| K093340 | PASR/QUIETNITE | Exact Supplies , Ltd. | 2010-06-11 | LRK |
| K093710 | THE MOSES APPLIANCE | Allen J. Moses, Dds, Ltd. | 2010-05-12 | LRK |
| K090436 | AIRWAYEASE MAS | Orthoplant Dental Lab | 2010-04-16 | LRK |
| K092942 | VITAL SLEEPBrand page | The Snore Reliever Company, LLC | 2010-01-13 | LRK |
| K090911 | IST SNORING APPLIANCE | Dental Crafters | 2009-09-11 | LQZ |
| K082849 | SILENT SLEEP | Craniofacial Pain Center of Idaho | 2009-07-16 | LRK |
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | 2009-06-24 | LQZ |
| K090503 | ZQUIET MOUTHPIECEBrand page | Sleeping Well, LLC | 2009-03-10 | LRK |
| K083209 | ACRYLIC HERBST SPLINT APPLIANCE | Specialty Appliance Works, Inc. | 2009-01-27 | LRK |
| K081965 | MPOWRX SNORING SOLUTIONBrand page | Mpowrx Health and Wellness Products, Inc. | 2008-10-27 | LRK |
| K072731 | ENDSNOR | Dockstader Orthodontic Lab, Inc. | 2008-06-12 | LRK |
| K073004 | SOMNOMED BFLEXBrand page | Somnomed, Inc. | 2008-01-30 | LRK |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | Sybron Dental Specialties, Inc. | 2007-05-25 | LRK |
| K060795 | SOMNOFIT | Strategic Counsel Sarl | 2006-12-18 | LRK |
| K062333 | LAIMAD | Steven Lamberg, D.D.S | 2006-12-14 | LRK |
| K062951 | TAP III ANTI-SNORING DEVICEBrand page | Airway Management, Inc. | 2006-12-12 | LRK |
| K061688 | ANTI-SNORING / SLEEP APNEA DEVICE | Tomed Dr. Toussaint GmbH | 2006-09-08 | LRK |
| K061732 | TAP-TBrand page | Airway Management, Inc. | 2006-07-12 | LRK |
| K060744 | O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) | O'Brien Dental Lab, Inc. | 2006-06-02 | LRK |
| K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds | 2006-05-26 | LQZ |
| K060122 | SLEEP SPLINT | Nakagawa Dental Clinic | 2006-05-19 | LRK |
| K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENTBrand page | Airway Management, Inc. | 2006-05-17 | LRK |
| K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) | Bryan Keropian Dds | 2006-01-03 | LQZ |
| K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds | 2005-12-30 | LQZ |
| K051014 | SILENT PARTNER SERIES OSA APPLIANCES | Dreamwrx Dental Laboratory | 2005-08-09 | LRK |
| K050592 | SOMNOMED MAS RXABrand page | Somnomed, Ltd. | 2005-07-12 | LRK |
| K041184 | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION | Nti-Tss, Inc. | 2005-05-03 | LRK |
| K032410 | SNORENTI | James P Boyd | 2005-02-28 | LQZ |
| K042161 | ANTI-SNORING/SLEEP APNEA DEVICE | Rj & VK Bird Pty , Ltd. | 2004-10-27 | LRK |
| K040417 | PILLAR PALATAL IMPLANT SYSTEM | Restore Medical, Inc. | 2004-07-28 | LRK |
| K021569 | RESTFUL NIGHTS, IST-APPLIANCE | Ottawa Dental Laboratory | 2004-03-15 | LRK |
| K033823 | RESPIRONICS CUSTOM II ORAL APPLIANCE | Respironics, Inc. | 2004-02-06 | LRK |
| K033822 | RESPIRONICS CUSTOM I ORAL APPLIANCE | Respironics, Inc. | 2004-02-06 | LRK |
| K030440 | OASYS-ORAL AIRWAY SYSTEM | Mark Abramson, D.D.S., Inc. | 2003-08-26 | LRK |
| K023836 | THE SUAD DEVICE | Strong Dental, Inc. | 2003-07-08 | LRK |
| K022891 | THE BREATHE EZ ANTI-SNORING DEVICE | D&S Redhage | 2003-02-19 | LRK |
| K011723 | ANTI-SNORING DEVICE OR ASD | Pi Medical | 2002-12-18 | LRK |
| K022284 | SNORE-AID MAX | Dental Imagineers, LLC | 2002-12-10 | LRK |
| K013687 | NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER | Steven K. Sue | 2002-05-28 | LRK |
| K020893 | NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | Dennis R. Bailey, Dds | 2002-05-28 | LRK |
| K013808 | SLEEPBITE | Dental Imagineers, LLC | 2002-01-30 | LRK |
| K013049 | NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | Dennis R. Bailey, Dds | 2001-11-29 | LRK |
| K012142 | THE QUIET SLEEPER | Precision Dental Laboratories, Inc. | 2001-10-04 | LRK |
| K993381 | TONGUE STABILIZER DEVICE | University of Otago | 1999-12-21 | LRK |
| K991209 | ORAL SLEEP DISORDER AID | Perl-Rad Sleep Disorder Lab | 1999-09-22 | LRK |
| K991948 | DR. B'S MOUTHPIECE, MODEL 32129-10002 | Snore - Ezzer | 1999-09-02 | LRK |
| K981677 | REPOSE BONE SCREW SYSTEM | Influence, Inc. | 1999-08-27 | LRK |
| K991449 | SNORE-AID PLUS | Dental Imagineers, LLC | 1999-07-22 | LRK |
| K981923 | THE SNORE PEACE | The Snore Peace Group | 1998-08-24 | LRK |
| K980952 | SNORE-CURE ANTI-SNORING APPLIANCE | ORTHO-TAIN, Inc. | 1998-06-01 | LRK |
| K974531 | SNORE-EZZER | Snore - Ezzer | 1998-02-12 | LRK |
| K973884 | ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCEBrand page | Frantz Design, Inc. | 1998-01-09 | LRK |
| K963591 | SNORING CONTROL DEVICE | Kenneth Hilsen | 1998-01-09 | LRK |
| K971818 | SNOREX | Snorex (Nz) , Ltd. | 1997-12-18 | LQZ |
| K973038 | ADJUSTABLE THERASNORE | Distar, Inc. | 1997-11-12 | LRK |
| K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCEBrand page | Frantz Design, Inc. | 1997-09-29 | LRK |
| K972424 | SILENTNITEBrand page | Glidewell Laboratories | 1997-09-18 | LRK |
| K972023 | SLEEP-IN BONE SCREW SYSTEM | Influence, Inc. | 1997-08-25 | LRK |
| K972061 | TOA | W. Keith Thornton, D.D.S. | 1997-08-21 | LRK |
| K963063 | SNORE TEC | Marketing Technologies, Inc. | 1997-04-14 | LRK |
| K964516 | TAP | Nellcor Puritan Bennett, Inc. | 1997-01-24 | LRK |
| K962516 | TAP ANTI-SNORING DEVICEBrand page | Nellcor Puritan Bennett, Inc. | 1996-09-10 | LRK |
| K960673 | OSAP | Snorefree, Inc. | 1996-05-09 | LQZ |
| K955822 | REMOVABLE HERBST APPLIANCE | Univ. Dental Assoc. Department of Orthodontics | 1996-03-20 | LRK |
| K955503 | ADJUSTABLE PM POSITIONER | Jonathan A. Parker, D.D.S. | 1996-02-08 | LQZ |
| K955336 | SNOREFREE | Scott Feldman Dds & Norman Shapiro Dds | 1996-01-04 | LRK |
| K954530 | THE SILENCER | Silent Knights Ventures, Inc. | 1995-10-30 | LRK |
| K954324 | SNOR-X MOUTH GUARD | Snorex, Inc. | 1995-10-17 | LRK |
| K954128 | SNOREMASTER | D.D.S., Inc. | 1995-10-02 | LRK |
| K953293 | PM POSITIONER | Jonathan A. Parker, D.D.S. | 1995-09-15 | LQZ |
| K945820 | DESRA | D.S.R.A., Inc. | 1995-06-15 | LQZ |
| K946112 | ELASTOMERIC SLEEP APPLIANCE | Village Park Orthodontics | 1995-06-14 | LQZ |
| K950763 | LOWE KLEARWAY | Dr. Alan A. Lowe, Inc. | 1995-05-25 | LRK |
| K932932 | SNOREMASTER SNORE REMEDY | The Snoremaster Co. | 1995-02-10 | LQZ |
| K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. | 1994-02-09 | LQZ |
| K926382 | THERASNORE | Dr. Thomas E. Meade | 1993-07-08 | LRK |
| K922984 | ORTHODONTIC BITE | American Orthodontics | 1993-03-31 | LRK |
| K902790 | NAPA | G-Ortho Lab | 1990-09-19 | LQZ |
| K895189 | ADJUSTABLE SOFT PALATE LIFTER | Ortho Publications, Inc. | 1990-02-09 | LRK |
| K882303 | H&M ANTI-SNORING DEVICE | Hays & Meade, Inc. | 1989-04-14 | LRK |
| K874416 | DENTAL ANTI-SNORING DEVICE | Ortho Publications, Inc. | 1988-10-18 | LRK |
| K880956 | SNOAR(TM) OPEN AIRWAY APPLIANCE | Kent J. Toone, D.D.S. | 1988-05-11 | LQZ |
| K870501 | THE EQUALIZER AIRWAY DEVICE | Sleep Renewal, Inc. | 1987-03-04 | LQZ |
This lookup covers product codes LRK (Device, Anti-Snoring), LQZ (Device, Jaw Repositioning), PLC (Sleep Appliances With Patient Monitoring). Implants, nerve stimulators, CPAP machines and home sleep tests use other product codes or pathways and are not included yet. See the overview for brand pages.
How to check a clearance yourself
- Open FDA's 510(k) Premarket Notification database.
- Search by the 510(k) number (it starts with K) or by the device or company name.
- Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
- If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.