510(k) Report

Devices descending from K050592

86 later devices reach Somnomed Mas Rxa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+1K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+1K133390NDX Dorsal ApplianceInstitute For Quality Resource Management20140—
+1K133683MICR02 Osa DeviceMicrodental, Inc.201411—
+1K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+1K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+1K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+1K130558Somnodent Herbst; Classic, FlexSomnomed, Inc.201316—
+1K121285Oravan OsaNew Jersey Snoring Solutions20132—
+1K113516Therasom-CastFamily Dental Services, P.C.20132—
+1K122475Zquiet Pro-PlusSleeping Well, LLC20120—
+1K113201Narval CCResmed Sas201115—
+1K111207Respire Blue SeriesRespire Medical201111—
+1K102521Pantino Pro PositinerSomnomed, Inc.20110—
+1K103076DynaflexDyna Flex201129—
+1K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+1K073004Somnomed BflexSomnomed, Inc.200832—
+2K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+2K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+2K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+2K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+2K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+2K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.20190—
+2K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+2K183443SomnoDent AvantSomnomed, Inc.20192—
+2K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+2K181123ApnoDent ApplianceApnomed, Inc.20180—
+2K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+2K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+2K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+2K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.20165—
+2K162306SomnoDent ALPHASomnomed, Inc.20160—
+2K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+2K152292Respire Blue Series-EFRespire Medical Holding20150—
+2K152159Oravan HerbstOravanosa, LLC20150—
+2K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+2K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+2K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+2K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+2K131138Respire Pink Series - HerbstRespire Medical20137—
+2K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+2K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+2K121344NU SleepRh Associates, LLC20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K121340Somnodent G2Somnomed, Inc.201218—
+2K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+2K090436Airwayease MasOrthoplant Dental Lab20100—
+3K261366VirtusSomnomed, Inc.20260—
+3K252942ShaeferHShaeferh, LLC20260—
+3K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+3K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+3K233497Rest Assure SystemSomnomed, Inc.20240—
+3K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+3K232735EMA 3DEma Sleep Incorporated20241—
+3K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+3K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+3K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+3K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+3K203712The SlideBiotex, Inc.20210—
+3K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+3K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+3K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+3K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+3K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+3K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab20170—
+3K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+3K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+3K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+3K160239Tap 3, Tap 1Airway Management, Inc.20160—
+3K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+3K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+3K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+4K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+4K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+4K252698NightGuard Aire MaxNightguard Express, LLC20250—
+4K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+4K234089DNA ApplianceVivos Therapeutics20240—
+4K230495Serena Sleep Night GuardMeris Investment Group20231—
+4K191320Slow Wave DS8Slow Wave, Inc.20205—
+4K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+4K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+5K233754AIO BreatheAiomega, LLC20241—
+5K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+5K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+5K214096Respire ClearRespire Medical, LLC20220—
+6K252525AIO BreatheAiomega, LLC20250—