Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Anti-Snoring Device

FDA device type “Device, Anti-Snoring”.

FDA codeLRKClass221 CFR872.5570Pathway510(k)CategoryAnti-snoring & jaw-repositioning devices
Companies listing it
10192 makers
Brands and models
325
510(k) clearances
21746 in five years
FDA name
Device, Anti-Snoring
1988: 11989: 11990: 11993: 21995: 41996: 31997: 71998: 51999: 52001: 22002: 52003: 32004: 52005: 32006: 82007: 12008: 32009: 32010: 82011: 102012: 102013: 92014: 112015: 62016: 102017: 72018: 102019: 132020: 52021: 102022: 112023: 52024: 62025: 142026: 1019801990200020102020

510(k) clearances per year, 1976–2026

Companies that list LRK

101 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Prismatik Dentalcraft, Inc.United StatesMakerDreamTAP · Elastic Mandibular Advancement (EMA) appliance · EndSnorZ Sleep Appliance, ENDSNZ, ENDSNZU, ENDSNZL · flexTAP® · +7562026
Vivos Therapeutics, Inc.United StatesMakerDNA · Vivos EMA Now · Vivos mmRNA Appliance · Vivos mRNA Appliance · +232024
Fissiontech LLCUnited StatesMakerAdvanced Anti Snoring Device 4 Clear/ Advanced Anti Snoring Device 4 Blue · BestSelected Anti Snoring Device · Difiney Advanced Anti Snoring Device 4 · Difiney Anti Snoring Device · +132025
Good Sleep Co Pte LtdSingaporeMakerAvera · Hushd Pro Avera · HUSHD PRO Z-LINK · Z-LINK32025
Somnomed, Inc.United StatesMakerClassic · Classic Lingual-Less · Flex · Fusion Classic · +12112026
ProSomnus Sleep TechnologiesUnited StatesMakerMicrO2 Sleep Device · Prosomnus [CA] Low Profile Sleep and snore Device with Compliance Monitoring · Prosomnus [IA] Sleep Device · Prosomnus [PH] Sleep and Snore Device · +832026
Modern Dental Laboratory Co., Ltd.ChinaMakerAnti-Snoring Device · EMA Custom, EMA First Step · Emerald Herbst · Moses Appliance · +222024
Aiomega, LLCUnited StatesMakerAIO BREATHE22025
Sleeping Well, LLCUnited StatesMakerZQuiet · ZQuiet Advance Anti-Snoring Mouthpiece · ZQuiet Pro-Flex · ZQuiet Pro-Plus · +162022
True Function Laboratory IncUnited StatesMakerElastic Mandibular Advancement (EMA) · True Function Adjustable Herbst Appliances · TrueDorsal32026
Koncept Innovators, LLCUnited StatesMakerBright Guard Pro 2 · Dormiva Anti-Snoring Mouth Guard · Eliminator Pro 2 · Intelliguard Pro · +922026
Shinrin-Yoku Traders LLCUnited StatesMakerSilentZPro · SilentZPro (BlueTech) · SilentZPro 2 · SilentZPro 2 (Large) · +712022
Dongguan Yiyao Science & Technology Development Co., Ltd.ChinaMakerAnti Snore Mouthpiece, Device, Anti-Snoring-BreazTek Anti Snore Mouthpiece, Kaitse ANTI SNORE MOUTHPIECE · Honpouyi Anti Snore Mouthpiece · QuietLab Pro12025
EMA-Sleep IncUnited StatesMakerEMA 3D12024
OnirisFranceMakerOniris Plus · ONIRIS Pro12025
Innovative Health Technologies (NZ) LimitedNew ZealandMakerAVEOtsd12023
Oscimed SASwitzerlandMakerAnti-snore Mouth Guard+12024
QuietLabUnited Arab EmiratesMakerQuietLab Pro12025
Solbaro Co.,Ltd.South KoreaMakerSNOR LOCK12022
Splintek Inc.United StatesMaker—12025
Philips Medical Systems International BVNetherlandsMakerSnoreSilencer162010
Medtronic, Inc.United StatesMakerAirvance · Anti-snoring device112014
Airway Management, Inc.United StatesMakerdreamTAP · MyTAP · Nylon flexTAP · TAP 3 Elite · +352018
Panthera Dental Inc.CanadaMakerDigital - Sleep Apnea Device · Panthera Anti-Snoring X3 Device · The Panthera Anti-Snoring Device52020
Always More Marketing IncUnited StatesMakerZyppah · Zyppah A · Zyppah Anti-Snoring Appliance · Zyppah V42019
Gergens Orthodontic LabUnited StatesMakerAcylic Herbst · mmRNA appliance · mRNA Appliance · TAP32017
Comfort Acrylics, Inc.United StatesMakerTAP 1 · TAP 332019
Ranir, LLCUnited StatesMaker—22011
Crane Dental LaboratoryUnited StatesMakerCrane Acrylic Herbst Appliance · EMA · Lamberg SleepWell · Respire Blue Series · +322019
Selane Products, Inc.United StatesMakerApnoDent · ATG/SM-OSA APPLIANCES · Clear Sleep22017
Apnea Sciences CorporationUnited StatesMakerApneaRx · Sleep Silent · SnoreMD · SnoreRx22017
Sleep Science Partners, Inc.United StatesMakerPureSleep · PureSleep (OTC) · PureSleep Pro22019
Advanced Brain Monitoring, Inc.United StatesMakerApnea Guard22014
Orthoapnea S.L.SpainMakerCLASSIC · NOA22021
The Snore Reliever CompanyUnited StatesMakerVital Sleep22021
The Myerson Company LimitedTrinidad & TobagoMakerEMA · EMA CAD · EMA Custom12017
National Dentex LLCUnited StatesMakerClearDream · Elastic Mandibular Advancement (EMA) Appliance · EMA · SomnoDent MAS · +212012
Sicat GmbH & Co. KGGermanyMakerSICAT OPTISLEEP12016
Apnomed, Inc.United StatesMakerApnoDent appliance12018
American Sleep DentistryUnited StatesMakerAmerican Sleep Dentistry Oral Appliance · ASD Oral Appliance · ASD Oral Appliances12017
Biotex, Inc.United StatesMakerThe Slide12021
Drake Precision Dental Laboratory, Inc.United StatesMakerBIALEX Lead Screen Check · ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE · TAP 3 TL12020
Diamond Orthotic Laboratory, LLCUnited StatesMakerDDSO (Diamond Digital Sleep Orthotic) · SnoreHook12020
MPowRx Health and Wellness Products 2012 Inc.CanadaMakerGood Morning Snore Solution · MPowRx Snoring Solution12020
Slow Wave, Inc.United StatesMakerSlow Wave DS812020
SmartGuard Rx IncUnited StatesMakerSmartGuard Anti-Snore Device12021
Five Star Orthodontic Laboratory & Supply, Inc.United StatesMakerDreamTAP · Elastic Mandibular Advancement (EMA) · mmRNA · TAP III Anti-Snoring Device · +1——
Great Lakes Dental Technologies, Ltd.United StatesMakerHerbst Sleep Appliance · Klearway Appliance · Medley Gold——
IDOC Dental LabUnited StatesMakerEMA——
Xiamen Yizhou Imp. & Exp. Co., Ltd.ChinaMakerBright Guard Pro 2 · Dormiva Anti-Snoring Mouth Guard · Eliminator Pro 2 · Intelliguard Pro · +10——
AdvanTech Plastics, LLCUnited StatesMakerZQUIET——
Life Science Outsourcing, Inc.United StatesMakerElevo Set Snoring Intervention Device——
Ortho Solutions LCUnited StatesMakerAdjustable Herbst · Dorsal Appliance · EMA · LISA II® · +11——
Laboratorios Dentales de Zona Franca, S.A.Costa RicaMakerElastic Mandibular Advancement (EMA) appliance · Silent Nite sl——
Digital Dental Depot LimitedHong Kong SAR ChinaMakerAdvanced Anti-Snoring Device 4 Clear/Blue · Anti-Snoring Device · Device, anti-snoring · Device, jaw repositioning——
DOC BRANDS, Inc.United StatesMakerDentemp SleepTight · SleepEasy Mouthguard · SleepEasy Mouthpiece · SleepTight · +2——
Shenzhen Sany Pioneer Technology Co.,LtdChinaMakerEverness Anti Snoring Mouthpiece L07 · Innoflow Anti Snoring Mouthpiece L07 · Innoflow Anti Snoring Mouthpiece L08 · Innoflow Anti Snoring Mouthpiece L09 · +8——
Shenzhen Osmiler Intelligent Technology Co., Ltd.ChinaMakerDevice, anti-snoring · Device, jaw repositioning · Medical device data system · Oximeter · +1——
Aurum Group Ltd.CanadaMakerDNA · mRNA · Snoring device——
Johns Dental LabUnited StatesMakerElastic Mandibular Advancement (EMA) appliance · EMA 3D · Vivos DNA · Vivos mmRNA · +1——
Apex Dental Sleep LabUnited StatesMakerEMA · EMA 3D · Kava · MMRNA · +3——
Digital Dental DepotChinaMakeranit-snoring · Device, jaw repositioning——
Hexa Ceram Co., Ltd.ThailandMakerBlue Series EF · Pink Series EF · Pink Series with DentiTrac · Respire Blue Series · +2——
Burbank Dental LabUnited StatesMakerMyerson EMA · Tap III——
New Image Dental Laboratory, Inc.United StatesMakerEMA 3D——
Oral Arts Laboratory, Inc.United StatesMakerEMA · EMA 3D · QuietNite · TAP III——
Tomed GmbHGermanyMakerSOMNOGUARD · SomnoGuard SP Pro · SomnoGuard SP Soft · SomnoGuard SPX · +4——
Global Dent Aids Pvt. Ltd.IndiaMaker———
Dental Prosthetic Services, Inc.United StatesMakerEMA · EMA 3D · Oasys · Oasys Herbst · +1——
M R Utility products Private limitedIndiaMakerSnore Gaurd——
GCDL, LLCUnited StatesMakerEMA · Tap 3 Tap 1——
Open Airway Dental SolutionsAustraliaMakerDevice, anti-snoring · Device, anti-snoring - O2Vent Optima; O2Vent Optima Connect; O2Vent Optima Mini; O2Vent Optima Mini Connect——
Shun Hsiang Plastic Co.,ltd.TaiwanMakerAdvanced Anti Snoring Device 4 Clear/ Advanced Anti Snoring Device 4 Blue · Difiney Advanced Anti Snoring Device 4 · Difiney Anti Snoring Device——
Zhuhai DS Dental Technology Co., LTDChinaMakerDevice, anti-snoring——
Artisan Laboratories IncUnited StatesMakerElastic Mandibular Advancement (Ema) App · Tap 3, Dream Tap——
Bialex LabUnited StatesMakerBIALEX Lead Screen Check · ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE——
Gelb PracticeUnited StatesMakerairVataTM——
Island Dental Lab dba Emerald Dental LabUnited StatesMakerEmerald Herbst——
Serena SleepUnited StatesMakerSerena Sleep Ace · Serena Sleep Elevate——
Shenzhen Kesite Digital Technology Co., Ltd.ChinaMakerPoZent Tongue Stabilizing Device Mouthpiece; IFGZQU Tongue Stabilizing Device Mouthpiece · Upverxi Snore Mouthguard; SnoreBandit Anti-Snoring Appliance——
Sleep Joy International LLCUnited StatesMakerLambergSleepWell-Smartrusion (LSW-S)——
The Metz Dental LaboratoryUnited StatesMakerHealthy Sleep Appliance · The Metz Appliance——
Boyd Research, Inc.United StatesMakerSnoreHook——
Inventex MedicalUnited StatesMakerZQuiet——
Ironwood Industries IncUnited StatesMakerSnoring Device——
NewsomFranceMakerBluePro——
R-dent Dental Laboratory, IncUnited StatesMakerElastomeric Mandibular Advancement (EMA)——
Reazeal Corp.United StatesMakerREAZEAL ANTI SNORE MOUTHPIECE——
Stelray Plastic Products, Inc.United StatesMakerDevice, Anti-snoring——
Zepeda Dental LabUnited StatesMakerTAP, EMA——
3DPX MedicalUnited StatesMaker———
Dongyang City Yonoel Outdoor Products Co.,LtdChinaMaker———
Myerson LLCUnited StatesContract manufacturerEMA CAD disc · EMA Custom Kit · EMA thermoforming discs, Bite pads & Buttons, Elastic Straps12023
Sleepcare, LLCUnited StatesRepacker / relabelerDaybreak Device Classic · Daybreak Device Neo12026
Hongkong Loyal Beauty Technology LimitedHong Kong SAR ChinaForeign exporterDevice, Anti-Snoring——
Braebon Medical CorporationCanadaRepacker / relabelerSnoreByte——
SnoreLessNow LLCUnited StatesRepacker / relabelerAnti-Snore Mouth Guard+ · Somnofit-S Anti-Snore Mouth Guard+——
Sterilization Services of Georgia, Inc.United StatesContract sterilizerBone screw · Pillar palatal——
Quality Packaging Specialists InternationalUnited StatesRepacker / relabelerPure Sleep (OTC)——
CEVA Logistics LimitedUnited KingdomForeign exporter———
CEVA Logistics Netherlands BVNetherlandsForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
20 Oct 2026K262937PDR Airway DevicePark Dental Research Corp
6 Oct 2026K260136ForzaTrue Function Laboratory Inc
27 Aug 2026K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.
31 Jul 2026K261912SnØreNegatØrDnB Innovations, LLC
12 Jun 2026K261366VirtusSomnomed, Inc.
11 Jun 2026K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC
14 May 2026K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, LLC
10 Apr 2026K252942ShaeferHShaeferh, LLC
3 Mar 2026K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd.
2 Mar 2026K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. Usa Inc.
18 Dec 2025K252976Park Dental Nylon MADPark Dental Research Corp
5 Dec 2025K253868QuietLab ProQuietLab
25 Nov 2025K252161Hushd AveraGood Sleep Co Pte Ltd
6 Nov 2025K252525AIO BreatheAiomega, LLC
3 Nov 2025K252698NightGuard Aire MaxNightguard Express, LLC
29 Oct 2025K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech LLC
24 Oct 2025K251784Hushd Pro Z-LinkGood Sleep Co Pte Ltd
22 Oct 2025K251628Mandibular Advancement Device L07Dcstar, Inc.
3 Oct 2025K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd.
17 Sep 2025K243752Double Tube Herbst ApplianceThe Tmj Clinic PC
11 Sep 2025K252374Nylon flexTAP(R)Airway Technologies D/B/A Airway Management
4 Sep 2025K250353Oniris; Oniris PlusOniris
19 May 2025K250122SleepRight Snore AidSplintek Inc.
8 May 2025K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech LLC
16 Sep 2024K234089DNA ApplianceVivos Therapeutics, Inc.
9 May 2024K232025Hushd Pro AveraGood Sleep Co Pte Ltd
3 May 2024K232735EMA 3DEMA-Sleep Inc
18 Apr 2024K233850Difiney Anti Snoring DeviceFissiontech LLC
14 Feb 2024K240427airVata™Gelb Practice Solutions, Inc.
16 Jan 2024K231138Aniti-Snore Mouthguard+Oscimed SA
28 Nov 2023K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.
14 Nov 2023K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc.
18 Sep 2023K231663The AVEOtsd (Tongue Stabilizing Device) MouthpieceInnovative Health Technologies (NZ) Limited
1 Sep 2023K223901ApneaRX ProApnea Sciences Coporation
10 May 2023K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental
30 Dec 2022K222872DNA ApplianceVivos Therapeutics, Inc.
2 Dec 2022K220688SilentZPro 2.0Shinrin-Yoku Traders LLC
10 Nov 2022K222475SNOR LOCKSolbaro Co.,Ltd.
27 Oct 2022K221322CUSTMBITE Snoring SystemDental Choice Holdings, LLC
24 Oct 2022K222127Soft Palate ElevatorThe Tmj Clinic PC
6 Oct 2022K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringProSomnus Sleep Technologies
8 Sep 2022K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.
15 Jun 2022K213088ZQuiet AdvanceSleeping Well, LLC
31 May 2022K214096Respire ClearRespire Medical, LLC
15 Feb 2022K210636MorpheusS4S UK , Ltd.
27 Jan 2022K213475Elevo Snoring Intervention SetZelegent, Inc.
26 Oct 2021K211069EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc.
23 Aug 2021K200657SmartGuard Anti-Snoring DeviceSmartGuard Rx Inc
19 Aug 2021K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)
1 Jul 2021K210910Snore BanditSnorebandit, LLC
16 Jun 2021K210694Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc.
10 Mar 2021K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment Group
25 Feb 2021K203477ClassicOrthoapnea S.L.
19 Feb 2021K203462Advanced Dental ApplianceDasoft Partners
12 Feb 2021K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.
14 Jan 2021K201719Vital SleepThe Snore Reliever Company
23 Nov 2020K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC
20 Nov 2020K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringProSomnus Sleep Technologies
3 Sep 2020K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory, LLC
5 Feb 2020K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings
3 Jan 2020K193239MPowRx Snoring Solution (also known as Good Morning Snore Solution)MPowRx Health and Wellness Products 2012 Inc.
11 Dec 2019K191618SleepTight Mouthpiece STZMichael D Williams Dds PA
17 Sep 2019K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory
29 Aug 2019K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.
17 Jul 2019K183270Silent Nite slPrismatik Dentalcraft, Inc.
2 Jul 2019K190687Twilite ApplianceStephen J Harkins, Dds, PC
7 Jun 2019K190051TD ClipZephyr Sleep Technologies, Inc.
8 May 2019K183443SomnoDent AvantSomnomed, Inc.
11 Apr 2019K190058PureSleep (OTC use)Sleep Science Partners, Inc.
8 Mar 2019K173064ZAPnea Oral ApplianceB. Fareid, Dds, PC
13 Feb 2019K182661Kava and Kava with HerbstSketchpad Innovations, LLC
11 Feb 2019K180691TrueDorsal DevicesTrue Function Laboratory Inc
24 Jan 2019K182312Zyppah Anti-Snoring DeviceAlways More Marketing Inc
11 Jan 2019K182202SLEEPAPPComfort Acrylics, Inc.
6 Dec 2018K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.
21 Nov 2018K181123ApnoDent ApplianceApnomed, Inc.
16 Nov 2018K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited
31 Aug 2018K181482myTAP2Airway Management, Inc.
10 Jul 2018K172991Advanced Dental ApplicanceDasoft Partners
26 Jun 2018K173856Express 4 Sleep appliance/CPAP Sidekick applianceMoses Appliances, LLC
12 Jun 2018K180124ZQuietSleeping Well, LLC
26 Mar 2018K172760REST EAZY ApplianceInsert Molding Solutions, Inc.
22 Feb 2018K171576The Panthera Anti-Snoring X3 DevicePanthera Dental Inc.
2 Jan 2018K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.
28 Nov 2017K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine
24 Nov 2017K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory Inc
18 Aug 2017K170825SnoreRxApnea Sciences Corporation
11 Jul 2017K171316O2Vent WOventus Manufacturing Pty, Ltd.
8 Jun 2017K163580ASD Oral AppliancesAmerican Sleep Dentistry
26 May 2017K170692Respire Pink Series with DentiTracRespire Medical Holding
7 Feb 2017K161980Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLC
15 Dec 2016K162192BlueProBluesom
9 Nov 2016K152660HYPNOSPADSomnics, Inc.
23 Sep 2016K161832O2VENT TOventus Manufacturing Pty, Ltd.
20 Sep 2016K162306SomnoDent ALPHASomnomed, Inc.
1 Sep 2016K160531NoiselezzFirma Ingemarsson
9 Aug 2016K153200SnoreRxApnea Sciences Corporation
12 Jul 2016K160123ApinatorAllen J. Moses, Dds, Ltd.
31 Mar 2016K153291SICAT OPTISLEEPSicat GmbH & Co. KG
21 Mar 2016K150566OnirisSas Oniris
17 Mar 2016K160234OVENTOventus Manufacturing Pty, Ltd.
7 Dec 2015K152292Respire Blue Series-EFRespire Medical Holding
29 Oct 2015K152159Oravan HerbstOravanosa, LLC
27 Aug 2015K150572Respire Pink Series-Herbst-EFRespire Medical Holding
17 Jul 2015K142651The Moses Express applianceAllen J. Moses, Dds, Ltd.
22 May 2015K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell , Ltd.
15 Apr 2015K143591Dorsal ApplianceGergens Orthodontic Lab
15 Dec 2014K143244The Panthera Anti-Snoring DevicePanthera Dental Inc.
12 Dec 2014K140663THERASNOREDistar, LLC
16 Oct 2014K133390NDX DORSAL APPLIANCEInstitute For Quality Resource Management
11 Sep 2014K140429CRANE ACRYLIC HERBST APPLIANCECrane Dental Laboratory
25 Jul 2014K140777ZQUIET-SASleeping Well, LLC
24 Jul 2014K133683MICR02 OSA DEVICEMicrodental, Inc.
26 Jun 2014K140435MEDLEY GOLDAmerican Dental Sleep Medicine, Ip, LLC
20 Jun 2014K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXSomnomed, Inc.
29 May 2014K132506SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASYMichael D Williams Dds PA
8 May 2014K130067MRNA APPLIANCEBiomodeling Solutions, Lls
25 Apr 2014K132933THE MOSES ELITE APPLIANCEAllen J. Moses, Dds, Ltd.
18 Dec 2013K130797LUCO HYBRID OSA APPLIANCELuco Hybrid Osa Appliance, Inc.
18 Oct 2013K130504ASA ORAL APPLIANCESAmerican Sleep Association
9 Sep 2013K131138RESPIRE PINK SERIES - HERBSTRespire Medical, LLC
17 Jul 2013K113126ACRYLIC HERBST APPLIANCEGergens Orthodontic Lab
17 May 2013K130558SOMNODENT HERBST; CLASSIC, FLEXSomnomed, Inc.
5 Apr 2013K123410HEALTHY SLEEP APPLIANCEHealthy Sleep Dental Laboratory
8 Mar 2013K121285ORAVAN OSANew Jersey Snoring Solutions
10 Jan 2013K122391MEDTRONIC XOMED, INC.Medtronic, Inc.
4 Jan 2013K113516THERASOM-CASTFamily Dental Services, P.C.
7 Dec 2012K122475ZQUIET PRO-PLUSSleeping Well, LLC
17 Oct 2012K121344NU SLEEPRh Associates, LLC
28 Sep 2012K121761SOMNOGUARD SP SOFTTomed Dr. Toussaint GmbH
27 Jun 2012K120372DR GREENBURGS HYBRID VACUUMAlways More Marketing Inc
27 Jun 2012K120371DR GREENBURGS HYBRID ACRYLICAlways More Marketing Inc
11 Jun 2012K113022PURESLEEPSleep Science Partners, Inc.
30 May 2012K121340SOMNODENT G2Somnomed, Inc.
23 Mar 2012K103704REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMPZephyr Sleep Technologies, Inc.
1 Mar 2012K113569APNEARXApnea Science Corporation
10 Feb 2012K110623PILLAR PALATAL IMPLANT SYSTEMMedtronic, Inc.
23 Dec 2011K111680DR. GREENSBURG'S HYBRIDAlways More Marketing Inc
16 Nov 2011K112205SNORERX 9.0Consumer Health Products, Inc.
23 Aug 2011K111207RESPIRE BLUE SERIESRespire Medical, LLC
22 Jul 2011K111110APNEA GUARDAdvanced Brain Monitoring, Inc.
22 Jul 2011K111009ACRYLIC HERBST APPLIANCEEmbassy Dental Laboratory
25 May 2011K102463GOOD NIGHTLarry V Connell, Dmd
12 May 2011K101155AURADORM (NEUROMUSCULAR SLEEP)Sleepwright
28 Mar 2011K102521PANTINO PRO POSITINERSomnomed, Inc.
25 Feb 2011K103004SNORE GUARDRanir, LLC
23 Feb 2011K103076DYNAFLEXDyna Flex
19 Nov 2010K100185SLEEP APPSleep Medicine Network, Inc.
8 Sep 2010K102118SNORE GUARD ADVANCERanir, LLC
18 Aug 2010K101709LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)Steven B. Lamberg, Dds
22 Jun 2010K093407ZQUIET MOUTHPIECESleeping Well, LLC
11 Jun 2010K093340PASR/QUIETNITEExact Supplies , Ltd.
12 May 2010K093710THE MOSES APPLIANCEAllen J. Moses, Dds, Ltd.
16 Apr 2010K090436AIRWAYEASE MASOrthoplant Dental Lab
13 Jan 2010K092942VITAL SLEEPThe Snore Reliever Company
16 Jul 2009K082849SILENT SLEEPCraniofacial Pain Center of Idaho
10 Mar 2009K090503ZQUIET MOUTHPIECESleeping Well, LLC
27 Jan 2009K083209ACRYLIC HERBST SPLINT APPLIANCESpecialty Appliance Works, Inc.
27 Oct 2008K081965MPOWRX SNORING SOLUTIONMpowrx Health and Wellness Products, Inc.
12 Jun 2008K072731ENDSNORDockstader Orthodontic Lab, Inc.
30 Jan 2008K073004SOMNOMED BFLEXSomnomed, Inc.
25 May 2007K070327REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATORSybron Dental Specialties
18 Dec 2006K060795SOMNOFITStrategic Counsel Sarl
14 Dec 2006K062333LAIMADSteven Lamberg, D.D.S
12 Dec 2006K062951TAP III ANTI-SNORING DEVICEAirway Management, Inc.
8 Sep 2006K061688ANTI-SNORING / SLEEP APNEA DEVICETomed Dr. Toussaint GmbH
12 Jul 2006K061732TAP-TAirway Management, Inc.
2 Jun 2006K060744O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)O'Brien Dental Lab, Inc.
19 May 2006K060122SLEEP SPLINTNakagawa Dental Clinic
17 May 2006K060388TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENTAirway Management, Inc.
9 Aug 2005K051014SILENT PARTNER SERIES OSA APPLIANCESDreamwrx Dental Laboratory
12 Jul 2005K050592SOMNOMED MAS RXASomnomed, Inc.
3 May 2005K041184NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATIONNti-Tss, Inc.
27 Oct 2004K042161ANTI-SNORING/SLEEP APNEA DEVICERj & VK Bird Pty , Ltd.
28 Jul 2004K040417PILLAR PALATAL IMPLANT SYSTEMRestore Medical, Inc.
15 Mar 2004K021569RESTFUL NIGHTS, IST-APPLIANCEOttawa Dental Laboratory
6 Feb 2004K033823RESPIRONICS CUSTOM II ORAL APPLIANCEPhilips Medical Systems International BV
6 Feb 2004K033822RESPIRONICS CUSTOM I ORAL APPLIANCEPhilips Medical Systems International BV
26 Aug 2003K030440OASYS-ORAL AIRWAY SYSTEMMark Abramson, D.D.S., Inc.
8 Jul 2003K023836THE SUAD DEVICEStrong Dental, Inc.
19 Feb 2003K022891THE BREATHE EZ ANTI-SNORING DEVICED&S Redhage
18 Dec 2002K011723ANTI-SNORING DEVICE OR ASDPi Medical
10 Dec 2002K022284SNORE-AID MAXDental Imagineers, LLC
28 May 2002K020893NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCEDennis R. Bailey, Dds
28 May 2002K013687NOSE BREATHE MOUTHPIECE FOR HEAVY SNORERSteven K. Sue
30 Jan 2002K013808SLEEPBITEDental Imagineers, LLC
29 Nov 2001K013049NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCEDennis R. Bailey, Dds
4 Oct 2001K012142THE QUIET SLEEPERPrecision Dental Laboratories, Inc.
21 Dec 1999K993381TONGUE STABILIZER DEVICEUniversity of Otago
22 Sep 1999K991209ORAL SLEEP DISORDER AIDPerl-Rad Sleep Disorder Lab
2 Sep 1999K991948DR. B'S MOUTHPIECE, MODEL 32129-10002Snore - Ezzer
27 Aug 1999K981677REPOSE BONE SCREW SYSTEMInfluence, Inc.
22 Jul 1999K991449SNORE-AID PLUSDental Imagineers, LLC
24 Aug 1998K981923THE SNORE PEACEThe Snore Peace Group
1 Jun 1998K980952SNORE-CURE ANTI-SNORING APPLIANCEORTHO-TAIN, Inc.
12 Feb 1998K974531SNORE-EZZERSnore - Ezzer
9 Jan 1998K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCEFrantz Design, Inc.
9 Jan 1998K963591SNORING CONTROL DEVICEKenneth Hilsen
12 Nov 1997K973038ADJUSTABLE THERASNOREDistar, LLC
29 Sep 1997K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCEFrantz Design, Inc.

Showing the 200 most recent of 217.

Official records: FDA product classification for LRK · 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