510(k) Report

Devices descending from K882303

202 later devices reach H&M Anti-Snoring Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102118Snore Guard AdvanceRanir, LLC201029—
+1K060122Sleep SplintNakagawa Dental Clinic20060—
+1K022284Snore-Aid MaxDental Imagineers, LLC20020—
+1K014079DR. Hays Bite GuardInventive Resources, Inc.200233—
+1K991449Snore-Aid PlusDental Imagineers, LLC19991—
+1K980952Snore-Cure Anti-Snoring ApplianceORTHO-TAIN, Inc.19980—
+1K962516Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc.1996152—
+2K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group20124—
+2K111066Migra Tab, Quicksplint MigraineMigratherapy, LLC20117—
+2K103004Snore GuardRanir, LLC201128—
+2K082723GrindguardGrind Guard Technologies, LLC200910—
+2K061122Night GuardAlpine Oral Care, LLC20070—
+2K063229Rest Assured Nite ProtectorRanir, LLC20067—
+2K060795SomnofitStrategic Counsel Sarl20060—
+2K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc.200615—
+2K061688Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH200622—
+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—
+2K024261Dental ProtectorDental Concepts, LLC200320—
+2K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage200375—
+2K972061TOAW. Keith Thornton, D.D.S.199795—
+3K252374Nylon flexTAP (R)Airway Technologies D/B/A Airway Management20250—
+3K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC20230—
+3K210011JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC20212—
+3K203477ClassicOrthoapnea S.L.20210—
+3K202465Night Guard3D Diagnostix, Inc.20200—
+3K171529Snorer's FriendScope Healthcare Technologies Pty, Ltd.20180—
+3K170985Urbanek DeviceTmj Services, LLC20174—
+3K161980Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLC20170—
+3K152660HypnospadSomnics, Inc.20160—
+3K161832O2VENT TOventus Manufacturing Pty, Ltd.20167—
+3K162306SomnoDent ALPHASomnomed, Inc.20160—
+3K160234OVENTOventus Manufacturing Pty, Ltd.20168—
+3K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+3K140777Zquiet-SASleeping Well, LLC20140—
+3K133037GrindguardGrind Guard Technologies, LLC20146—
+3K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+3K121761Somnoguard SP SoftTomed Dr. Toussaint GmbH20122—
+3K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+3K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+3K113022PuresleepSleep Science Partners, Inc.20121—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+3K112205Snorerx 9.0Consumer Health Products, Inc.201126—
+3K111207Respire Blue SeriesRespire Medical201111—
+3K111110Apnea GuardAdvanced Brain Monitoring, Inc.20112—
+3K101155Auradorm (Neuromuscular Sleep)Sleepwright20110—
+3K102521Pantino Pro PositinerSomnomed, Inc.20110—
+3K103076DynaflexDyna Flex201129—
+3K094020Grind NO More Generation IIRanir, LLC20100—
+3K090911Ist Snoring ApplianceDental Crafters20090—
+3K091792Rest Assured Generation II Dental ProtectorRanir Corporation20095—
+3K090503Zquiet MouthpieceSleeping Well, LLC200910—
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+3K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc.200717—
+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—
+3K981744Combination Toa with Nasal Mask Holder and Universal Nasal Mask HolderW. Keith Thornton, D.D.S.19980—
+4K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+4K253868QuietLab ProQuietLab, LLC20250—
+4K241369LIJIA Night GuardLijia, LLC20241—
+4K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+4K182820The PODAdvanced Facialdontics, LLC20193—
+4K190051TD ClipZephyr Sleep Technologies, Inc.20190—
+4K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+4K181099Bright GuardKoncept Innovators, LLC20195—
+4K170578True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc.20170—
+4K171316O2Vent WOventus Manufacturing Pty, Ltd.20176—
+4K160531NoiselezzFirma Ingemarsson20160—
+4K153200SnoreRxApnea Sciences Corporation201622—
+4K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+4K150566OnirisSas Oniris20160—
+4K152292Respire Blue Series-EFRespire Medical Holding20150—
+4K140663TherasnoreDistar, LLC20140—
+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—
+4K132469The Bite GuardInternational Profit Builders, Inc.20140—
+4K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+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—
+4K113569ApnearxApnea Science Corporation20124—
+4K120103Rest Assured Generation Iii Dental ProtectorRanir, LLC20120—