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Product code LRK

FDA-cleared anti-snoring devices

All 217 FDA 510(k) clearances under product code LRK — "Device, Anti-Snoring", Class II, 21 CFR 872.5570.

Source: FDA 510(k) premarket notification database via openFDA. Retrieved (FDA data last updated November 2, 2026).

FDA groups devices by product code. Code LRK is "Device, Anti-Snoring" (FDA classification record). The most recent clearance is K262937 ("PDR Airway Device", October 20, 2026); the oldest is K874416 (October 18, 1988).

Brand pages for this product code

All 217 records, newest first

FDA 510(k) records under product code LRK
510(k) numberDevice name (as filed)ApplicantDecision dateProduct codeDecision
K262937PDR Airway DevicePark Dental Research Corp.Ardmore, OKLRKSubstantially Equivalent
K260136ForzaTrue Function Laboratory, Inc.La Mesa, CALRKSubstantially Equivalent
K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.Singapore, SGLRKSubstantially Equivalent
K261912SnØreNegatØrDnB Innovations, LLCKeller, TXLRKSubstantially Equivalent
K261366VirtusSomnomed, Inc.Plano, TXLRKSubstantially Equivalent
K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCSheridan, WYLRKSubstantially Equivalent
K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.Myrtle Beach, SCLRKSubstantially Equivalent
K252942ShaeferHShaeferh, LLCBoston, MALRKSubstantially Equivalent
K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.Singapore, SGLRKSubstantially Equivalent
K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.Helnsvale, AULRKSubstantially Equivalent
K252976Park Dental Nylon MADPark Dental Research Corp.Ardmore, OKLRKSubstantially Equivalent
K253868QuietLab ProQuietLab, LLCNew York, NYLRKSubstantially Equivalent
K252161Hushd AveraGood Sleep CO Pte , Ltd.Singapore, SGLRKSubstantially Equivalent
K252525AIO BreatheAiomega, LLCTyler, TXLRKSubstantially Equivalent
K252698NightGuard Aire MaxNightguard Express, LLCLewisville, TXLRKSubstantially Equivalent
K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLCNew York, NYLRKSubstantially Equivalent
K251784Hushd Pro Z-LinkGood Sleep CO Pte , Ltd.Singapore, SGLRKSubstantially Equivalent
K251628Mandibular Advancement Device L07Dcstar, Inc.New York, NYLRKSubstantially Equivalent
K250028Anti Snore MouthpieceDongguan Yiyao Science & Technology Development Co., Ltd.Dongguan, CNLRKSubstantially Equivalent
K243752Double Tube Herbst ApplianceThe Tmj Clinic PCPortland, ORLRKSubstantially Equivalent
K252374Nylon flexTAP(R)Airway Technologies D/B/A Airway ManagementFarmers Branch, TXLRKSubstantially Equivalent
K250353Oniris; Oniris PlusOnirisRueil Malmaison, FRLRKSubstantially Equivalent
K250122SleepRight Snore AidSplintek, Inc.Lenexa, KSLRKSubstantially Equivalent
K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLCNew York, NYLRKSubstantially Equivalent
K234089DNA ApplianceVivos TherapeuticsMurray, KYLRKSubstantially Equivalent
K232025Hushd Pro AveraGood Sleep CO Pte , Ltd.Singapore, SGLRKSubstantially Equivalent
K232735EMA 3DEma Sleep IncorporatedSpicewood, TXLRKSubstantially Equivalent
K233850Difiney Anti Snoring DeviceFissiontech, LLCNew York, NYLRKSubstantially Equivalent
K240427airVata™Gelb Practice Solutions, Inc.Dix Hills, NYLRKSubstantially Equivalent
K231138Aniti-Snore Mouthguard+Oscimed SASuisse, CHLRKSubstantially Equivalent
K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.Murray, KYLRKSubstantially Equivalent
K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc.Irvine, CALRKSubstantially Equivalent
K231663The AVEOtsd (Tongue Stabilizing Device) MouthpieceInnovative Health Technologies (Nz), Ltd.Dunedin, NZLRKSubstantially Equivalent
K223901ApneaRX ProApnea Sciences CoporationAliso Viejo, CALRKSubstantially Equivalent
K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald DentalValley Stream, NYLRKSubstantially Equivalent
K222872DNA ApplianceVivos Therapeutics, Inc.Murray, KYLRKSubstantially Equivalent
K220688SilentZPro 2.0Shinrin-Yoku Traders, LLCSherwood, ORLRKSubstantially Equivalent
K222475SNOR LOCKSolbaro Co., Ltd.Gamgok-Myeon, Eumseong-Gun, KRLRKSubstantially Equivalent
K221322CUSTMBITE Snoring SystemDental Choice Holdings, LLCLouisville, KYLRKSubstantially Equivalent
K222127Soft Palate ElevatorThe Tmj Clinic PCPortland, ORLRKSubstantially Equivalent
K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringProsomnus Sleep TechnologiesPleasanton, CALRKSubstantially Equivalent
K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.Belfast, IELRKSubstantially Equivalent
K213088ZQuiet AdvanceSleeping Well, LLCShelburne, VTLRKSubstantially Equivalent
K214096Respire ClearRespire Medical, LLCBrooklyn, NYLRKSubstantially Equivalent
K210636MorpheusS4S UK , Ltd.Sheffield, GBLRKSubstantially Equivalent
K213475Elevo Snoring Intervention SetZelegent, Inc.La Jolla, CALRKSubstantially Equivalent
K211069EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc.Irvine, CALRKSubstantially Equivalent
K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc.Layton, UTLRKSubstantially Equivalent
K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)Highland Ranch, COLRKSubstantially Equivalent
K210910Snore BanditSnorebandit, LLCLas Vegas, NVLRKSubstantially Equivalent
K210694Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc.Irvine, CALRKSubstantially Equivalent
K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment GroupLakeland, MNLRKSubstantially Equivalent
K203477ClassicOrthoapnea S.L.Malaga, ESLRKSubstantially Equivalent
K203462Advanced Dental ApplianceDasoft PartnersSan Diego, CALRKSubstantially Equivalent
K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.Malaga, ESLRKSubstantially Equivalent
K201719Vital SleepThe Snore Reliever Company, LLCNorth Bergen, NJLRKSubstantially Equivalent
K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLCMyrtle Beach, SCLRKSubstantially Equivalent
K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringProsomnus Sleep Technologies, Inc.Pleasanton, CALRKSubstantially Equivalent
K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic LaboratoryLa Mesa, CALRKSubstantially Equivalent
K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical HoldingsBrooklyn, NYLRKSubstantially Equivalent
K193239MPowRx Snoring Solution (also known as Good Morning Snore Solution)Mpowrx Health and Wellness Products 2012, Inc.Calgary, CALRKSubstantially Equivalent
K191618SleepTight Mouthpiece STZMichael D Williams Dds PADavie, FLLRKSubstantially Equivalent
K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.Rochester, NYLRKSubstantially Equivalent
K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.Indooroopilly, AULRKSubstantially Equivalent
K183270Silent Nite slPrismatik Dentalcraft, Inc.Irvine, CALRKSubstantially Equivalent
K190687Twilite ApplianceStephen J Harkins, Dds, PCTucson, AZLRKSubstantially Equivalent
K190051TD ClipZephyr Sleep Technologies, Inc.Calgary, CALRKSubstantially Equivalent
K183443SomnoDent AvantSomnomed, Inc.Plano, TXLRKSubstantially Equivalent
K190058PureSleep (OTC use)Sleep Science Partners, Inc.Larkspur, CALRKSubstantially Equivalent
K173064ZAPnea Oral ApplianceB. Fareid, Dds, PCKingsburg, CALRKSubstantially Equivalent
K182661Kava and Kava with HerbstSketchpad Innovations, LLCSan Diego, CALRKSubstantially Equivalent
K180691TrueDorsal DevicesTrue Function Laboratory, Inc.La Mesa, CALRKSubstantially Equivalent
K182312Zyppah Anti-Snoring DeviceAlways More MarketingCalabasas, CALRKSubstantially Equivalent
K182202SLEEPAPPComfort Acrylics, Inc.Camas, WALRKSubstantially Equivalent
K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.Irvine, CALRKSubstantially Equivalent
K181123ApnoDent ApplianceApnomed, Inc.Bellevue, WALRKSubstantially Equivalent
K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) LimitedEllesmere Port, GBLRKSubstantially Equivalent
K181482myTAP2Airway Management, Inc.Carrollton, TXLRKSubstantially Equivalent
K172991Advanced Dental ApplicanceDasoft PartnersSan Diego, CALRKSubstantially Equivalent
K173856Express 4 Sleep appliance/CPAP Sidekick applianceMoses Appliances, LLCIndian Wells, CALRKSubstantially Equivalent
K180124ZQuietSleeping Well, LLCShelburne, VTLRKSubstantially Equivalent
K172760REST EAZY ApplianceInsert Molding Solutions, Inc.Cumming, GALRKSubstantially Equivalent
K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.Quebec City, CALRKSubstantially Equivalent
K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.Unley, AULRKSubstantially Equivalent
K170053Meridian PMThe Center For Craniofacial & Dental Sleep MedicineSugarland, TXLRKSubstantially Equivalent
K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.La Mesa, CALRKSubstantially Equivalent
K170825SnoreRxApnea Sciences CorporationAliso Viejo, CALRKSubstantially Equivalent
K171316O2Vent WOventus Manufacturing Pty, Ltd.Indooroopilly, AULRKSubstantially Equivalent
K163580ASD Oral AppliancesAmerican Sleep DentistryCedar City, UTLRKSubstantially Equivalent
K170692Respire Pink Series with DentiTracRespire Medical HoldingBrooklyn, NYLRKSubstantially Equivalent
K161980Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLCMaitland, FLLRKSubstantially Equivalent
K162192BlueProBluesomOrvault, FRLRKSubstantially Equivalent
K152660HYPNOSPADSomnics, Inc.Hsinchu County, TWLRKSubstantially Equivalent
K161832O2VENT TOventus Manufacturing Pty, Ltd.Indooroopilly, AULRKSubstantially Equivalent
K162306SomnoDent ALPHASomnomed, Inc.Frisco, TXLRKSubstantially Equivalent
K160531NoiselezzFirma IngemarssonCharlottenlund, DKLRKSubstantially Equivalent
K153200SnoreRxApnea Sciences CorporationAliso Viejo, CALRKSubstantially Equivalent
K160123ApinatorAllen J. Moses, Dds, Ltd.Chicago, ILLRKSubstantially Equivalent
K153291SICAT OPTISLEEPSicat GmbH & Co. KGBonn, DELRKSubstantially Equivalent
K150566OnirisSas OnirisChaville, FRLRKSubstantially Equivalent
K160234OVENTOventus Manufacturing Pty, Ltd.Brisbane, AULRKSubstantially Equivalent
K152292Respire Blue Series-EFRespire Medical HoldingBrooklyn, NYLRKSubstantially Equivalent
K152159Oravan HerbstOravanosa, LLCWest Orange, NJLRKSubstantially Equivalent
K150572Respire Pink Series-Herbst-EFRespire Medical HoldingBrooklyn, NYLRKSubstantially Equivalent
K142651The Moses Express applianceAllen J. Moses, Dds, Ltd.Chicago, ILLRKSubstantially Equivalent
K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell , Ltd.London, GBLRKSubstantially Equivalent
K143591Dorsal ApplianceGergens Orthodontic LabPhoenix, AZLRKSubstantially Equivalent
K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.Quebec City, CALRKSubstantially Equivalent
K140663THERASNOREDistar, LLCAlbuquerque, NMLRKSubstantially Equivalent
K133390NDX DORSAL APPLIANCEInstitute For Quality Resource ManagementSt. Louis, MOLRKSubstantially Equivalent
K140429CRANE ACRYLIC HERBST APPLIANCECrane Dental Laboratory, Inc.Rochester, NYLRKSubstantially Equivalent
K140777ZQUIET-SASleeping Well, LLCLeola, PALRKSubstantially Equivalent
K133683MICR02 OSA DEVICEMicrodental, Inc.Dublin, CALRKSubstantially Equivalent
K140435MEDLEY GOLDAmerican Dental Sleep Medicine, Ip, LLCWexford, PALRKSubstantially Equivalent
K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXSomnomed, Inc.Frisco, TXLRKSubstantially Equivalent
K132506SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASYMichael D Williams Dds PADavie, FLLRKSubstantially Equivalent
K130067MRNA APPLIANCEBiomodeling Solutions, LlsBeaverton, ORLRKSubstantially Equivalent
K132933THE MOSES ELITE APPLIANCEAllen J. Moses, Dds, Ltd.Chicago, ILLRKSubstantially Equivalent
K130797LUCO HYBRID OSA APPLIANCELuco Hybrid Osa Appliance, Inc.Kingston, CALRKSubstantially Equivalent
K130504ASA ORAL APPLIANCESAmerican Sleep AssociationChesterland, OHLRKSubstantially Equivalent
K131138RESPIRE PINK SERIES - HERBSTRespire MedicalWoodland Hills, CALRKSubstantially Equivalent
K113126ACRYLIC HERBST APPLIANCEGergens Orthodontic LabDunlap, ILLRKSubstantially Equivalent
K130558SOMNODENT HERBST; CLASSIC, FLEXSomnomed, Inc.Frisco, TXLRKSubstantially Equivalent
K123410HEALTHY SLEEP APPLIANCEHealthy Sleep Dental LaboratoryBonita Springs, FLLRKSubstantially Equivalent
K121285ORAVAN OSANew Jersey Snoring SolutionsWest Orange, NJLRKSubstantially Equivalent
K122391MEDTRONIC XOMED, INC.Medtronic Xomed, Inc.Jacksonville, FLLRKSubstantially Equivalent
K113516THERASOM-CASTFamily Dental Services, P.C.Duluth, GALRKSubstantially Equivalent
K122475ZQUIET PRO-PLUSSleeping Well, LLCShelburne, VTLRKSubstantially Equivalent
K121344NU SLEEPRh Associates, LLCWoodland Hills, CALRKSubstantially Equivalent
K121761SOMNOGUARD SP SOFTTomed Dr. Toussaint GmbHHolderness, NHLRKSubstantially Equivalent
K120372DR GREENBURGS HYBRID VACUUMAlways More Marketing, Inc.Las Vegas, NVLRKSubstantially Equivalent
K120371DR GREENBURGS HYBRID ACRYLICAlways More Marketing, Inc.Las Vegas, NVLRKSubstantially Equivalent
K113022PURESLEEPSleep Science Partners, Inc.Larkspur, CALRKSubstantially Equivalent
K121340SOMNODENT G2Somnomed, Inc.Frisco, TXLRKSubstantially Equivalent
K103704REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMPZephyr Sleep Technologies, Inc.Calgary; Alberta, CALRKSubstantially Equivalent
K113569APNEARXApnea Science CorporationAliso Viejo, CALRKSubstantially Equivalent
K110623PILLAR PALATAL IMPLANT SYSTEMMedtronic Xomed, Inc.Jacksonville, FLLRKSubstantially Equivalent
K111680DR. GREENSBURG'S HYBRIDAlways More Marketing, Inc.Las Vegas, NVLRKSubstantially Equivalent
K112205SNORERX 9.0Consumer Health Products, Inc.Aliso Viejo, CALRKSubstantially Equivalent
K111207RESPIRE BLUE SERIESRespire MedicalWoodland Hills, CALRKSubstantially Equivalent
K111009ACRYLIC HERBST APPLIANCEEmbassy Dental LaboratoryChesterland, OHLRKSubstantially Equivalent
K111110APNEA GUARDAdvanced Brain Monitoring, Inc.Bonita Springs, FLLRKSubstantially Equivalent
K102463GOOD NIGHTLarry V Connell, DmdYakima, WALRKSubstantially Equivalent
K101155AURADORM (NEUROMUSCULAR SLEEP)SleepwrightSanta Fe, NMLRKSubstantially Equivalent
K102521PANTINO PRO POSITINERSomnomed, Inc.Denton, TXLRKSubstantially Equivalent
K103004SNORE GUARDRanir, LLCWashington, DCLRKSubstantially Equivalent
K103076DYNAFLEXDyna FlexAustin, TXLRKSubstantially Equivalent
K100185SLEEP APPSleep Medicine Network, Inc.Portland, ORLRKSubstantially Equivalent
K102118SNORE GUARD ADVANCERanir, LLCWashington, DCLRKSubstantially Equivalent
K101709LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)Steven B. Lamberg, DdsRichmond, VALRKSubstantially Equivalent
K093407ZQUIET MOUTHPIECESleeping Well, LLCCrofton, MDLRKSubstantially Equivalent
K093340PASR/QUIETNITEExact Supplies , Ltd.Watlington, Oxfordshire, GBLRKSubstantially Equivalent
K093710THE MOSES APPLIANCEAllen J. Moses, Dds, Ltd.Chicago, ILLRKSubstantially Equivalent
K090436AIRWAYEASE MASOrthoplant Dental LabBella Vista, New South Wales, AULRKSubstantially Equivalent
K092942VITAL SLEEPThe Snore Reliever Company, LLCLaguna Niguel, CALRKSubstantially Equivalent
K082849SILENT SLEEPCraniofacial Pain Center of IdahoBoise, IDLRKSubstantially Equivalent
K090503ZQUIET MOUTHPIECESleeping Well, LLCCrofton, MDLRKSubstantially Equivalent
K083209ACRYLIC HERBST SPLINT APPLIANCESpecialty Appliance Works, Inc.Cumming, GALRKSubstantially Equivalent
K081965MPOWRX SNORING SOLUTIONMpowrx Health and Wellness Products, Inc.Austin, TXLRKSubstantially Equivalent
K072731ENDSNORDockstader Orthodontic Lab, Inc.Fresno, CALRKSubstantially Equivalent
K073004SOMNOMED BFLEXSomnomed, Inc.Denton, TXLRKSubstantially Equivalent
K070327REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATORSybron Dental Specialties, Inc.Orange, CALRKSubstantially Equivalent
K060795SOMNOFITStrategic Counsel SarlLeesburg, VALRKSubstantially Equivalent
K062333LAIMADSteven Lamberg, D.D.SWashington, DCLRKSubstantially Equivalent
K062951TAP III ANTI-SNORING DEVICEAirway Management, Inc.Dallas, TXLRKSubstantially Equivalent
K061688ANTI-SNORING / SLEEP APNEA DEVICETomed Dr. Toussaint GmbHBensheim, DELRKSubstantially Equivalent
K061732TAP-TAirway Management, Inc.Dallas, TXLRKSubstantially Equivalent
K060744O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)O'Brien Dental Lab, Inc.Corvallis, ORLRKSubstantially Equivalent
K060122SLEEP SPLINTNakagawa Dental ClinicMineola, NYLRKSubstantially Equivalent
K060388TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENTAirway Management, Inc.Dallas, TXLRKSubstantially Equivalent
K051014SILENT PARTNER SERIES OSA APPLIANCESDreamwrx Dental LaboratoryLos Angeles, CALRKSubstantially Equivalent
K050592SOMNOMED MAS RXASomnomed, Ltd.Stillwater, MNLRKSubstantially Equivalent
K041184NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATIONNti-Tss, Inc.Rancho Santa Fe, CALRKSubstantially Equivalent
K042161ANTI-SNORING/SLEEP APNEA DEVICERj & VK Bird Pty , Ltd.Middle Park, Victoria, AULRKSubstantially Equivalent
K040417PILLAR PALATAL IMPLANT SYSTEMRestore Medical, Inc.Roseville, MNLRKSubstantially Equivalent
K021569RESTFUL NIGHTS, IST-APPLIANCEOttawa Dental LaboratoryCrofton, MDLRKSubstantially Equivalent
K033823RESPIRONICS CUSTOM II ORAL APPLIANCERespironics, Inc.Murrysville, PALRKSubstantially Equivalent
K033822RESPIRONICS CUSTOM I ORAL APPLIANCERespironics, Inc.Murrysville, PALRKSubstantially Equivalent
K030440OASYS-ORAL AIRWAY SYSTEMMark Abramson, D.D.S., Inc.Redwood City, CALRKSubstantially Equivalent
K023836THE SUAD DEVICEStrong Dental, Inc.Sterling, VALRKSubstantially Equivalent
K022891THE BREATHE EZ ANTI-SNORING DEVICED&S RedhageNew Haven, MOLRKSubstantially Equivalent
K011723ANTI-SNORING DEVICE OR ASDPi MedicalMinneapolis, MNLRKSubstantially Equivalent
K022284SNORE-AID MAXDental Imagineers, LLCOcean, NJLRKSubstantially Equivalent
K013687NOSE BREATHE MOUTHPIECE FOR HEAVY SNORERSteven K. SueHonolulu, HILRKSubstantially Equivalent
K020893NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCEDennis R. Bailey, DdsEnglewood, COLRKSubstantially Equivalent
K013808SLEEPBITEDental Imagineers, LLCOcean, NJLRKSubstantially Equivalent
K013049NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCEDennis R. Bailey, DdsEnglewood, COLRKSubstantially Equivalent
K012142THE QUIET SLEEPERPrecision Dental Laboratories, Inc.Fargo, NDLRKSubstantially Equivalent
K993381TONGUE STABILIZER DEVICEUniversity of OtagoTonawanda, NYLRKSubstantially Equivalent
K991209ORAL SLEEP DISORDER AIDPerl-Rad Sleep Disorder LabCarmel, CALRKSubstantially Equivalent
K991948DR. B'S MOUTHPIECE, MODEL 32129-10002Snore - EzzerWaukesha, WILRKSubstantially Equivalent
K981677REPOSE BONE SCREW SYSTEMInfluence, Inc.Washington, DCLRKSubstantially Equivalent
K991449SNORE-AID PLUSDental Imagineers, LLCOcean, NJLRKSubstantially Equivalent
K981923THE SNORE PEACEThe Snore Peace GroupMission Viejo, CALRKSubstantially Equivalent
K980952SNORE-CURE ANTI-SNORING APPLIANCEORTHO-TAIN, Inc.Washington, DCLRKSubstantially Equivalent
K974531SNORE-EZZERSnore - EzzerWaukesha, WILRKSubstantially Equivalent
K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCEFrantz Design, Inc.Webster, TXLRKSubstantially Equivalent
K963591SNORING CONTROL DEVICEKenneth HilsenNew York, NYLRKSubstantially Equivalent
K973038ADJUSTABLE THERASNOREDistar, Inc.Winchester, VALRKSubstantially Equivalent
K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCEFrantz Design, Inc.Webster, TXLRKSubstantially Equivalent
K972424SILENTNITEGlidewell LaboratoriesNewport Beach, CALRKSubstantially Equivalent
K972023SLEEP-IN BONE SCREW SYSTEMInfluence, Inc.San Francisco, CALRKSubstantially Equivalent
K972061TOAW. Keith Thornton, D.D.S.Dallas, TXLRKSubstantially Equivalent
K963063SNORE TECMarketing Technologies, Inc.Bakersfield, CALRKSubstantially Equivalent
K964516TAPNellcor Puritan Bennett, Inc.Eden Prairie, MNLRKSubstantially Equivalent
K962516TAP ANTI-SNORING DEVICENellcor Puritan Bennett, Inc.Eden Prairie, MNLRKSubstantially Equivalent
K955822REMOVABLE HERBST APPLIANCEUniv. Dental Assoc. Department of OrthodonticsBuffalo, NYLRKSubstantially Equivalent
K955336SNOREFREEScott Feldman Dds & Norman Shapiro DdsWoodland Hills, CALRKSubstantially Equivalent
K954530THE SILENCERSilent Knights Ventures, Inc.Vancouver, CALRKSubstantially Equivalent
K954324SNOR-X MOUTH GUARDSnorex, Inc.Washington, DCLRKSubstantially Equivalent
K954128SNOREMASTERD.D.S., Inc.Half Moon Bay, CALRKSubstantially Equivalent
K950763LOWE KLEARWAYDr. Alan A. Lowe, Inc.Vancouver, B.C. V6k 4m1, CALRKSubstantially Equivalent
K926382THERASNOREDr. Thomas E. MeadeAlexandria, VALRKSubstantially Equivalent
K922984ORTHODONTIC BITEAmerican OrthodonticsSheboygan, WILRKSubstantially Equivalent
K895189ADJUSTABLE SOFT PALATE LIFTEROrtho Publications, Inc.Westfield, NJLRKSubstantially Equivalent
K882303H&M ANTI-SNORING DEVICEHays & Meade, Inc.Albuquerque, NMLRKSubstantially Equivalent
K874416DENTAL ANTI-SNORING DEVICEOrtho Publications, Inc.Westfield, NJLRKSubstantially Equivalent

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  1. Open FDA's 510(k) Premarket Notification database.
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  4. If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

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