510(k) Report

Devices descending from K926382

154 later devices reach Therasnore through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K180619BongoInnomed Healthscience, Inc.20181—
+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—
+5K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+5K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+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—
+6K252004enCore Night GuardEncore Guards20250—
+6K251778Remi Custom Night GuardRemi20251—
+6K233497Rest Assure SystemSomnomed, Inc.20240—
+6K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+6K232735EMA 3DEma Sleep Incorporated20241—
+6K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+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—
+6K203712The SlideBiotex, Inc.20210—
+6K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+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—
+6K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+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—
+7K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+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—
+7K234089DNA ApplianceVivos Therapeutics20240—
+7K233754AIO BreatheAiomega, LLC20241—
+7K230495Serena Sleep Night GuardMeris Investment Group20231—
+7K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+7K214096Respire ClearRespire Medical, LLC20220—
+8K252525AIO BreatheAiomega, LLC20250—