510(k) Report

Devices descending from K962516

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082723GrindguardGrind Guard Technologies, LLC200910—
+1K060795SomnofitStrategic Counsel Sarl20060—
+1K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc.200615—
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+1K061732TAP-TAirway Management, Inc.200632—
+1K060744O'brien Mpa (Mandibular Positioning Applicance)O'Brien Dental Lab, Inc.20060—
+1K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc.200651—
+1K051014Silent Partner Series Osa AppliancesDreamwrx Dental Laboratory20050—
+1K042161Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd.2004109—
+1K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc.200365—
+1K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage200375—
+1K022284Snore-Aid MaxDental Imagineers, LLC20020—
+1K972061TOAW. Keith Thornton, D.D.S.199795—
+2K252374Nylon flexTAP (R)Airway Technologies D/B/A Airway Management20250—
+2K203477ClassicOrthoapnea S.L.20210—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K161980Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLC20170—
+2K152660HypnospadSomnics, Inc.20160—
+2K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+2K162306SomnoDent ALPHASomnomed, Inc.20160—
+2K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+2K140777Zquiet-SASleeping Well, LLC20140—
+2K133037GrindguardGrind Guard Technologies, LLC20146—
+2K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+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—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K111207Respire Blue SeriesRespire Medical201111—
+2K111110Apnea GuardAdvanced Brain Monitoring, Inc.20112—
+2K102521Pantino Pro PositinerSomnomed, Inc.20110—
+2K103076DynaflexDyna Flex201129—
+2K090911Ist Snoring ApplianceDental Crafters20090—
+2K090503Zquiet MouthpieceSleeping Well, LLC200910—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds20068—
+2K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds20059—
+2K050592Somnomed Mas RxaSomnomed, Ltd.200586—
+2K981744Combination Toa with Nasal Mask Holder and Universal Nasal Mask HolderW. Keith Thornton, D.D.S.19980—
+3K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+3K253868QuietLab ProQuietLab, LLC20250—
+3K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+3K190051TD ClipZephyr Sleep Technologies, Inc.20190—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K181099Bright GuardKoncept Innovators, LLC20195—
+3K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+3K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+3K150566OnirisSas Oniris20160—
+3K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+3K152292Respire Blue Series-EFRespire Medical Holding20150—
+3K140663TherasnoreDistar, LLC20140—
+3K133390NDX Dorsal ApplianceInstitute For Quality Resource Management20140—
+3K133683MICR02 Osa DeviceMicrodental, Inc.201411—
+3K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+3K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+3K131138Respire Pink Series - HerbstRespire Medical20137—
+3K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+3K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K130558Somnodent Herbst; Classic, FlexSomnomed, Inc.201316—
+3K121285Oravan OsaNew Jersey Snoring Solutions20132—
+3K113516Therasom-CastFamily Dental Services, P.C.20132—
+3K122475Zquiet Pro-PlusSleeping Well, LLC20120—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K121344NU SleepRh Associates, LLC20120—
+3K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+3K113201Narval CCResmed Sas201115—
+3K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+3K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+3K073004Somnomed BflexSomnomed, Inc.200832—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+4K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+4K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+4K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+4K221369FBCC Night GuardFbcc, Inc.20223—
+4K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+4K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+4K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+4K181416Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.20190—
+4K190236O2Vent OptimaOventus Manufacturing Pty, Ltd.20195—
+4K183443SomnoDent AvantSomnomed, Inc.20192—
+4K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+4K181123ApnoDent ApplianceApnomed, Inc.20180—
+4K180619BongoInnomed Healthscience, Inc.20181—