510(k) Report

Devices descending from K962516

152 later devices reach Tap Anti-Snoring Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180124ZQuietSleeping Well, LLC20186—
+4K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+4K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+4K162816SML-OSA2 AppliancesSelane Products, Inc.20170—
+4K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+4K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.20165—
+4K152159Oravan HerbstOravanosa, LLC20150—
+4K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+4K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc.201512—
+4K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+4K143591Dorsal ApplianceGergens Orthodontic Lab20150—
+4K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+4K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+4K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+4K121340Somnodent G2Somnomed, Inc.201218—
+4K090436Airwayease MasOrthoplant Dental Lab20100—
+5K261366VirtusSomnomed, Inc.20260—
+5K252942ShaeferHShaeferh, LLC20260—
+5K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+5K252004enCore Night GuardEncore Guards20250—
+5K251778Remi Custom Night GuardRemi20251—
+5K233497Rest Assure SystemSomnomed, Inc.20240—
+5K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+5K232735EMA 3DEma Sleep Incorporated20241—
+5K230947C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc.20231—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+5K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+5K203712The SlideBiotex, Inc.20210—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—
+5K191320Slow Wave DS8Slow Wave, Inc.20205—
+5K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+5K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+5K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—
+5K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+5K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+5K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab20170—
+5K160239Tap 3, Tap 1Airway Management, Inc.20160—
+6K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+6K253641Owl Night GuardOwl Dental Lab, Inc.20260—
+6K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+6K252698NightGuard Aire MaxNightguard Express, LLC20250—
+6K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+6K234089DNA ApplianceVivos Therapeutics20240—
+6K233754AIO BreatheAiomega, LLC20241—
+6K230495Serena Sleep Night GuardMeris Investment Group20231—
+6K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+6K214096Respire ClearRespire Medical, LLC20220—
+7K252525AIO BreatheAiomega, LLC20250—