510(k) Report

Devices descending from K926382

154 later devices reach Therasnore through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+1K972061TOAW. Keith Thornton, D.D.S.199795—
+1K964516TAPNellcor Puritan Bennett, Inc.19970—
+1K962516Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc.1996152—
+2K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+2K161980Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLC20170—
+2K152660HypnospadSomnics, Inc.20160—
+2K162306SomnoDent ALPHASomnomed, Inc.20160—
+2K140777Zquiet-SASleeping Well, LLC20140—
+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—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K082723GrindguardGrind Guard Technologies, LLC200910—
+2K090503Zquiet MouthpieceSleeping Well, LLC200910—
+2K060795SomnofitStrategic Counsel Sarl20060—
+2K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc.200615—
+2K061732TAP-TAirway Management, Inc.200632—
+2K060744O'brien Mpa (Mandibular Positioning Applicance)O'Brien Dental Lab, Inc.20060—
+2K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc.200651—
+2K051014Silent Partner Series Osa AppliancesDreamwrx Dental Laboratory20050—
+2K042161Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd.2004109—
+2K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc.200365—
+2K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage200375—
+2K022284Snore-Aid MaxDental Imagineers, LLC20020—
+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—
+3K252374Nylon flexTAP (R)Airway Technologies D/B/A Airway Management20250—
+3K203477ClassicOrthoapnea S.L.20210—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+3K160531NoiselezzFirma Ingemarsson20160—
+3K150566OnirisSas Oniris20160—
+3K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+3K140663TherasnoreDistar, LLC20140—
+3K133037GrindguardGrind Guard Technologies, LLC20146—
+3K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K111207Respire Blue SeriesRespire Medical201111—
+3K111110Apnea GuardAdvanced Brain Monitoring, Inc.20112—
+3K102521Pantino Pro PositinerSomnomed, Inc.20110—
+3K103076DynaflexDyna Flex201129—
+3K093407Zquiet MouthpieceSleeping Well, LLC20108—
+3K090911Ist Snoring ApplianceDental Crafters20090—
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds20068—
+3K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds20059—
+3K050592Somnomed Mas RxaSomnomed, Ltd.200586—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K190051TD ClipZephyr Sleep Technologies, Inc.20190—
+4K181099Bright GuardKoncept Innovators, LLC20195—
+4K180124ZQuietSleeping Well, LLC20186—
+4K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+4K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+4K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+4K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+4K152292Respire Blue Series-EFRespire Medical Holding20150—
+4K133390NDX Dorsal ApplianceInstitute For Quality Resource Management20140—
+4K133683MICR02 Osa DeviceMicrodental, Inc.201411—
+4K140278Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc.201414—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130067Mrna ApplianceBiomodeling Solutions, Lls20145—
+4K130797Luco Hybrid Osa ApplianceLuco Hybrid Osa Appliance, Inc.20130—
+4K131138Respire Pink Series - HerbstRespire Medical20137—
+4K130130Atg/SM-Osa AppliancesSelane Products, Inc.201317—
+4K113126Acrylic Herbst ApplianceGergens Orthodontic Lab20132—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K130558Somnodent Herbst; Classic, FlexSomnomed, Inc.201316—
+4K121285Oravan OsaNew Jersey Snoring Solutions20132—
+4K113516Therasom-CastFamily Dental Services, P.C.20132—
+4K122475Zquiet Pro-PlusSleeping Well, LLC20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K121344NU SleepRh Associates, LLC20120—
+4K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+4K113201Narval CCResmed Sas201115—
+4K111009Acrylic Herbst ApplianceEmbassy Dental Laboratory20113—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K101709Lambergsleepwell- Smartrusion (LSW-S)Steven B. Lamberg, Dds20100—
+4K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K073004Somnomed BflexSomnomed, Inc.200832—
+5K243752Double Tube Herbst ApplianceThe Tmj Clinic PC20250—
+5K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+5K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+5K222872DNA ApplianceVivos Therapeutics, Inc.20222—
+5K221369FBCC Night GuardFbcc, Inc.20223—
+5K210203mmRNA applianceVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)20210—
+5K210910Snore BanditSnorebandit, LLC20210—
+5K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group20213—
+5K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+5K201719Vital SleepThe Snore Reliever Company, LLC20211—
+5K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC20206—
+5K191618SleepTight Mouthpiece STZMichael D Williams Dds PA20193—