510(k) Report

Devices descending from K882303

202 later devices reach H&M Anti-Snoring Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+4K113201Narval CCResmed Sas201115—
+4K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+4K093407Zquiet MouthpieceSleeping Well, LLC20108—
+4K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K073004Somnomed BflexSomnomed, Inc.200832—
+5K261912SnØreNegatØrDnB Innovations, LLC20260—
+5K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+5K243516Remi Custom Night GuardGrindguard, Inc.20250—
+5K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+5K232238Goyo Mouthpiece SDimedikorea20240—
+5K223901ApneaRX ProApnea Sciences Coporation20231—
+5K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+5K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+5K221369FBCC Night GuardFbcc, Inc.20223—
+5K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+5K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+5K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+5K203462Advanced Dental ApplianceDasoft Partners20210—
+5K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+5K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+5K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.20190—
+5K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+5K183443SomnoDent AvantSomnomed, Inc.20192—
+5K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+5K181123ApnoDent ApplianceApnomed, Inc.20180—
+5K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited20180—
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K180124ZQuietSleeping Well, LLC20186—
+5K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+5K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+5K170825SnoreRxApnea Sciences Corporation201721—
+5K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+5K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+5K162192BlueProBluesom20160—
+5K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.20165—
+5K152159Oravan HerbstOravanosa, LLC20150—
+5K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+5K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+5K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+5K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+5K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+5K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+5K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+5K121340Somnodent G2Somnomed, Inc.201218—
+5K090436Airwayease MasOrthoplant Dental Lab20100—
+6K261366VirtusSomnomed, Inc.20260—
+6K252942ShaeferHShaeferh, LLC20260—
+6K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+6K253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte., Ltd.20261—
+6K252161Hushd AveraGood Sleep CO Pte, Ltd.20250—
+6K252004enCore Night GuardEncore Guards20250—
+6K251628Mandibular Advancement Device L07Dcstar, Inc.20250—
+6K251778Remi Custom Night GuardRemi20251—
+6K250122SleepRight Snore AidSplintek, Inc.20250—
+6K233497Rest Assure SystemSomnomed, Inc.20240—
+6K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+6K232735EMA 3DEma Sleep Incorporated20241—
+6K233850Difiney Anti Snoring DeviceFissiontech, LLC20243—
+6K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+6K230495Serena Sleep Night GuardMeris Investment Group20231—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+6K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+6K200657SmartGuard Anti-Snoring DeviceSmartguard Rx, Inc.20212—
+6K203712The SlideBiotex, Inc.20210—
+6K210910Snore BanditSnorebandit, LLC20210—
+6K201719Vital SleepThe Snore Reliever Company, LLC20211—
+6K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC20201—
+6K191320Slow Wave DS8Slow Wave, Inc.20205—
+6K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+6K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+6K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+6K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+6K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+6K181482myTAP2Airway Management, Inc.20180—
+6K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+6K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab20170—
+6K160239Tap 3, Tap 1Airway Management, Inc.20160—
+7K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.20260—
+7K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+7K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC20260—
+7K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.20260—
+7K253641Owl Night GuardOwl Dental Lab, Inc.20260—
+7K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+7K252698NightGuard Aire MaxNightguard Express, LLC20250—
+7K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+7K250353Oniris; Oniris PlusOniris20250—
+7K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC20251—
+7K234089DNA ApplianceVivos Therapeutics20240—
+7K233754AIO BreatheAiomega, LLC20241—
+7K231138Aniti-Snore Mouthguard+Oscimed SA20240—
+7K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+7K214096Respire ClearRespire Medical, LLC20220—