510(k) Report

Devices descending from K042161

109 later devices reach Anti-Snoring/Sleep Apnea Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+1K050592Somnomed Mas RxaSomnomed, Ltd.200586—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+2K152660HypnospadSomnics, Inc.20160—
+2K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+2K133390NDX Dorsal ApplianceInstitute For Quality Resource Management20140—
+2K140777Zquiet-SASleeping Well, LLC20140—
+2K133683MICR02 Osa DeviceMicrodental, Inc.201411—
+2K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+2K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+2K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+2K130558Somnodent Herbst; Classic, FlexSomnomed, Inc.201316—
+2K121285Oravan OsaNew Jersey Snoring Solutions20132—
+2K113516Therasom-CastFamily Dental Services, P.C.20132—
+2K122475Zquiet Pro-PlusSleeping Well, LLC20120—
+2K121761Somnoguard SP SoftTomed Dr. Toussaint GmbH20122—
+2K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K113022PuresleepSleep Science Partners, Inc.20121—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K113201Narval CCResmed Sas201115—
+2K111207Respire Blue SeriesRespire Medical201111—
+2K102521Pantino Pro PositinerSomnomed, Inc.20110—
+2K103076DynaflexDyna Flex201129—
+2K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+2K090503Zquiet MouthpieceSleeping Well, LLC200910—
+2K073004Somnomed BflexSomnomed, Inc.200832—
+3K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+3K253868QuietLab ProQuietLab, LLC20250—
+3K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+3K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+3K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+3K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+3K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+3K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.20190—
+3K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+3K183443SomnoDent AvantSomnomed, Inc.20192—
+3K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K181123ApnoDent ApplianceApnomed, Inc.20180—
+3K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+3K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+3K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+3K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.20165—
+3K162306SomnoDent ALPHASomnomed, Inc.20160—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K150566OnirisSas Oniris20160—
+3K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+3K152292Respire Blue Series-EFRespire Medical Holding20150—
+3K152159Oravan HerbstOravanosa, LLC20150—
+3K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+3K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+3K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+3K140663TherasnoreDistar, LLC20140—
+3K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+3K131138Respire Pink Series - HerbstRespire Medical20137—
+3K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+3K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+3K121344NU SleepRh Associates, LLC20120—
+3K121340Somnodent G2Somnomed, Inc.201218—
+3K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+3K090436Airwayease MasOrthoplant Dental Lab20100—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K261366VirtusSomnomed, Inc.20260—
+4K252942ShaeferHShaeferh, LLC20260—
+4K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+4K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+4K233497Rest Assure SystemSomnomed, Inc.20240—
+4K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+4K232735EMA 3DEma Sleep Incorporated20241—
+4K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+4K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+4K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+4K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+4K203712The SlideBiotex, Inc.20210—
+4K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+4K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+4K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+4K180124ZQuietSleeping Well, LLC20186—
+4K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+4K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab20170—
+4K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+4K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+4K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+4K160239Tap 3, Tap 1Airway Management, Inc.20160—
+4K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+4K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+4K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+5K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+5K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+5K252698NightGuard Aire MaxNightguard Express, LLC20250—
+5K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+5K234089DNA ApplianceVivos Therapeutics20240—
+5K230495Serena Sleep Night GuardMeris Investment Group20231—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—