510(k) Report

Devices descending from K073004

32 later devices reach Somnomed Bflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.20190—
+1K183443SomnoDent AvantSomnomed, Inc.20192—
+1K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+1K130558Somnodent Herbst; Classic, FlexSomnomed, Inc.201316—
+1K121344NU SleepRh Associates, LLC20120—
+1K121340Somnodent G2Somnomed, Inc.201218—
+1K111207Respire Blue SeriesRespire Medical201111—
+1K090436Airwayease MasOrthoplant Dental Lab20100—
+2K261366VirtusSomnomed, Inc.20260—
+2K233497Rest Assure SystemSomnomed, Inc.20240—
+2K203712The SlideBiotex, Inc.20210—
+2K162306SomnoDent ALPHASomnomed, Inc.20160—
+2K152292Respire Blue Series-EFRespire Medical Holding20150—
+2K152159Oravan HerbstOravanosa, LLC20150—
+2K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+2K131138Respire Pink Series - HerbstRespire Medical20137—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+3K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+3K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab20170—
+3K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+3K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.20165—
+3K160239Tap 3, Tap 1Airway Management, Inc.20160—
+3K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+3K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+4K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+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—
+4K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+5K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+5K214096Respire ClearRespire Medical, LLC20220—
+5K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+6K254304iNOS intraoral biosensorAchaemenid, LLC20260—