510(k) Report

Devices descending from K130558

16 later devices reach Somnodent Herbst; Classic, Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152159Oravan HerbstOravanosa, LLC20150—
+1K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+2K162306SomnoDent ALPHASomnomed, Inc.20160—
+2K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+3K233497Rest Assure SystemSomnomed, Inc.20240—
+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—
+4K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+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—
+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—
+5K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+6K254304iNOS intraoral biosensorAchaemenid, LLC20260—