510(k) Report

Devices descending from K060388

51 later devices reach Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203477ClassicOrthoapnea S.L.20210—
+1K111207Respire Blue SeriesRespire Medical201111—
+1K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc.200615—
+1K061732TAP-TAirway Management, Inc.200632—
+2K252374Nylon flexTAP (R)Airway Technologies D/B/A Airway Management20250—
+2K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+2K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+2K152292Respire Blue Series-EFRespire Medical Holding20150—
+2K131138Respire Pink Series - HerbstRespire Medical20137—
+2K121344NU SleepRh Associates, LLC20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K111110Apnea GuardAdvanced Brain Monitoring, Inc.20112—
+2K102521Pantino Pro PositinerSomnomed, Inc.20110—
+2K103076DynaflexDyna Flex201129—
+2K090911Ist Snoring ApplianceDental Crafters20090—
+3K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+3K190051TD ClipZephyr Sleep Technologies, Inc.20190—
+3K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+3K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+3K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+3K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+3K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+3K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+3K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+3K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+3K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+3K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+4K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+4K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+4K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+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—
+4K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+4K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+4K181123ApnoDent ApplianceApnomed, Inc.20180—
+4K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+4K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+4K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+5K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+5K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+5K214096Respire ClearRespire Medical, LLC20220—
+5K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+5K191320Slow Wave DS8Slow Wave, Inc.20205—
+6K252942ShaeferHShaeferh, LLC20260—
+6K234089DNA ApplianceVivos Therapeutics20240—
+6K232735EMA 3DEma Sleep Incorporated20241—
+6K233754AIO BreatheAiomega, LLC20241—
+6K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+7K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+7K252525AIO BreatheAiomega, LLC20250—
+7K252698NightGuard Aire MaxNightguard Express, LLC20250—