FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K111110 |
ADVANCED BRAIN MONITORING, INC. |
APNEA GUARD |
07/22/2011 |
K060388 |
AIRWAY MANAGEMENT INC. |
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT |
05/17/2006 |
K062951 |
AIRWAY MANAGEMENT INC. |
TAP III ANTI-SNORING DEVICE |
12/12/2006 |
K061732 |
AIRWAY MANAGEMENT INC. |
TAP-T |
07/12/2006 |
K181482 |
Airway Management, Inc. |
myTAP2 |
08/31/2018 |
K160123 |
Allen J. Moses, DDS LTD |
Apinator |
07/12/2016 |
K093710 |
ALLEN J. MOSES, DDS, LTD. |
THE MOSES APPLIANCE |
05/12/2010 |
K132933 |
ALLEN J. MOSES, DDS, LTD. |
THE MOSES ELITE APPLIANCE |
04/25/2014 |
K142651 |
ALLEN J. MOSES, DDS, LTD. |
The Moses Express appliance |
07/17/2015 |
K182312 |
Always More Marketing |
Zyppah Anti-Snoring Device |
01/24/2019 |
K120371 |
ALWAYS MORE MARKETING INC |
DR GREENBURGS HYBRID ACRYLIC |
06/27/2012 |
K120372 |
ALWAYS MORE MARKETING INC |
DR GREENBURGS HYBRID VACUUM |
06/27/2012 |
K111680 |
ALWAYS MORE MARKETING INC |
DR. GREENSBURG'S HYBRID |
12/23/2011 |
K140435 |
AMERICAN DENTAL SLEEP MEDICINE, IP, LLC |
MEDLEY GOLD |
06/26/2014 |
K130504 |
AMERICAN SLEEP ASSOCIATION |
ASA ORAL APPLIANCES |
10/18/2013 |
K163580 |
AMERICAN SLEEP DENTISTRY |
ASD Oral Appliances |
06/08/2017 |
K113569 |
APNEA SCIENCE CORPORATION |
APNEARX |
03/01/2012 |
K223901 |
Apnea Sciences Coporation |
ApneaRX Pro |
09/01/2023 |
K153200 |
Apnea Sciences Corporation |
SnoreRx |
08/09/2016 |
K170825 |
Apnea Sciences Corporation |
SnoreRx |
08/18/2017 |
K181123 |
ApnoMed, Inc. |
ApnoDent Appliance |
11/21/2018 |
K173064 |
B. Fareid, DDS, PC |
ZAPnea Oral Appliance |
03/08/2019 |
K130067 |
BIOMODELING SOLUTIONS, LLS |
MRNA APPLIANCE |
05/08/2014 |
K162192 |
BlueSom |
BluePro |
12/15/2016 |
K182202 |
Comfort Acrylics, Inc. |
SLEEPAPP |
01/11/2019 |
K112205 |
CONSUMER HEALTH PRODUCTS, INC |
SNORERX 9.0 |
11/16/2011 |
K181416 |
Crane Dental Laboratory, Inc |
Sapphire Dorsal Comfort Fit |
09/17/2019 |
K140429 |
CRANE DENTAL LABORATORY, INC. |
CRANE ACRYLIC HERBST APPLIANCE |
09/11/2014 |
K082849 |
CRANIOFACIAL PAIN CENTER OF IDAHO |
SILENT SLEEP |
07/16/2009 |
K022891 |
D&S REDHAGE |
THE BREATHE EZ ANTI-SNORING DEVICE |
02/19/2003 |
K203462 |
DaSoft Partners |
Advanced Dental Appliance |
02/19/2021 |
K172991 |
DaSoft Partners |
Advanced Dental Applicance |
07/10/2018 |
K020893 |
DENNIS R. BAILEY, DDS |
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE |
05/28/2002 |
K013049 |
DENNIS R. BAILEY, DDS |
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE |
11/29/2001 |
K221322 |
Dental Choice Holdings LLC |
CUSTMBITE Snoring System |
10/27/2022 |
K022284 |
DENTAL IMAGINEERS, LLC |
SNORE-AID MAX |
12/10/2002 |
K013808 |
DENTAL IMAGINEERS, LLC. |
SLEEPBITE |
01/30/2002 |
K991449 |
DENTAL IMAGINEERS, LLC. |
SNORE-AID PLUS |
07/22/1999 |
K202499 |
Diamond Orthotic Laboratory |
Diamond Digital Sleep Orthotic (DDSO) |
09/03/2020 |
K973038 |
DISTAR, INC. |
ADJUSTABLE THERASNORE |
11/12/1997 |
K140663 |
DISTAR, LLC |
THERASNORE |
12/12/2014 |
K072731 |
DOCKSTADER ORTHODONTIC LAB, INC. |
ENDSNOR |
06/12/2008 |
K051014 |
DREAMWRX DENTAL LABORATORY |
SILENT PARTNER SERIES OSA APPLIANCES |
08/09/2005 |
K103076 |
DYNAFLEX |
DYNAFLEX |
02/23/2011 |
K111009 |
EMBASSY DENTAL LABORATORY |
ACRYLIC HERBST APPLIANCE |
07/22/2011 |
K093340 |
EXACT SUPPLIES LTD. |
PASR/QUIETNITE |
06/11/2010 |
K113516 |
FAMILY DENTAL SERVICES, P.C. |
THERASOM-CAST |
01/04/2013 |
K160531 |
FIRMA INGEMARSSON |
Noiselezz |
09/01/2016 |
K973884 |
FRANTZ DESIGN, INC. |
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE |
01/09/1998 |
K971794 |
FRANTZ DESIGN, INC. |
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE |
09/29/1997 |
K161980 |
FUSELIER ENTERPRISES, LLC |
Fuselier Intraoral Nighttime Device (FIND) |
02/07/2017 |
K113126 |
GERGENS ORTHODONTIC LAB |
ACRYLIC HERBST APPLIANCE |
07/17/2013 |
K143591 |
GERGENS ORTHODONTIC LAB |
Dorsal Appliance |
04/15/2015 |
K972424 |
GLIDEWELL LABORATORIES |
SILENTNITE |
09/18/1997 |
K220330 |
Greystone IP Ltd |
Soundly Anti Snoring Device |
09/08/2022 |
K123410 |
HEALTHY SLEEP DENTAL LABORATORY |
HEALTHY SLEEP APPLIANCE |
04/05/2013 |
K981677 |
INFLUENCE, INC. |
REPOSE BONE SCREW SYSTEM |
08/27/1999 |
K972023 |
INFLUENCE, INC. |
SLEEP-IN BONE SCREW SYSTEM |
08/25/1997 |
K231663 |
Innovative Health Technologies (NZ), Ltd |
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece |
09/18/2023 |
K172760 |
Insert Molding Solutions, Inc. |
REST EAZY Appliance |
03/26/2018 |
K133390 |
INSTITUTE FOR QUALITY RESOURCE MANAGEMENT |
NDX DORSAL APPLIANCE |
10/16/2014 |
K223624 |
Island Dental Lab, Inc dba Emerald Dental |
Emerald Herbst |
05/10/2023 |
K963591 |
KENNETH HILSEN |
SNORING CONTROL DEVICE |
01/09/1998 |
K201484 |
Koncept Innovators, LLC. |
Somnos Anti-Snoring Mouth Guard |
11/23/2020 |
K102463 |
LARRY V CONNELL, DMD |
GOOD NIGHT |
05/25/2011 |
K130797 |
LUCO HYBRID OSA APPLIANCE INC. |
LUCO HYBRID OSA APPLIANCE |
12/18/2013 |
K030440 |
MARK ABRAMSON, D.D.S., INC |
OASYS-ORAL AIRWAY SYSTEM |
08/26/2003 |
K963063 |
MARKETING TECHNOLOGIES, INC. |
SNORE TEC |
04/14/1997 |
K122391 |
MEDTRONIC XOMED, INC. |
MEDTRONIC XOMED, INC. |
01/10/2013 |
K110623 |
MEDTRONIC XOMED, INC. |
PILLAR PALATAL IMPLANT SYSTEM |
02/10/2012 |
K203606 |
Meris Investment Group |
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) |
03/10/2021 |
K191618 |
Michael D Williams DDS PA |
SleepTight Mouthpiece STZ |
12/11/2019 |
K132506 |
MICHAEL D. WILLIAMS,DDS PA |
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY |
05/29/2014 |
K133683 |
MICRODENTAL, INC. |
MICR02 OSA DEVICE |
07/24/2014 |
K173856 |
Moses Appliances LLC |
Express 4 Sleep appliance/CPAP Sidekick appliance |
06/26/2018 |
K193239 |
MPowRx Health and Wellness Products 2012 Inc |
MPowRx Snoring Solution (also known as Good Morning Snore Solution) |
01/03/2020 |
K081965 |
MPOWRX HEALTH AND WELLNESS PRODUCTS INC. |
MPOWRX SNORING SOLUTION |
10/27/2008 |
K060122 |
NAKAGAWA DENTAL CLINIC |
SLEEP SPLINT |
05/19/2006 |
K964516 |
NELLCOR PURITAN BENNETT, INC. |
TAP |
01/24/1997 |
K962516 |
NELLCOR PURITAN BENNETT, INC. |
TAP ANTI-SNORING DEVICE |
09/10/1996 |
K121285 |
NEW JERSEY SNORING SOLUTIONS |
ORAVAN OSA |
03/08/2013 |
K041184 |
NTI-TSS, INC. |
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION |
05/03/2005 |
K060744 |
O'BRIEN DENTAL LAB, INC. |
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) |
06/02/2006 |
K152159 |
OravanOSA, LLC |
Oravan Herbst |
10/29/2015 |
K980952 |
ORTHO-TAIN, INC. |
SNORE-CURE ANTI-SNORING APPLIANCE |
06/01/1998 |
K203477 |
Orthoapnea S.L. |
Classic |
02/25/2021 |
K202651 |
Orthoapnea S.L. |
NOA Sleep Apnea and Snoring Device |
02/12/2021 |
K090436 |
ORTHOPLANT DENTAL LAB |
AIRWAYEASE MAS |
04/16/2010 |
K021569 |
OTTAWA DENTAL LABORATORY |
RESTFUL NIGHTS, IST-APPLIANCE |
03/15/2004 |
K190236 |
Oventus Manufacturing PTY LTD |
O2Vent Optima |
08/29/2019 |
K161832 |
OVENTUS MANUFACTURING PTY LTD |
O2VENT T |
09/23/2016 |
K171316 |
Oventus Manufacturing Pty Ltd |
O2Vent W |
07/11/2017 |
K160234 |
OVENTUS MANUFACTURING PTY LTD |
OVENT |
03/17/2016 |
K143244 |
Panthera Dental Inc. |
The Panthera Anti-Snoring Device |
12/15/2014 |
K171576 |
Panthera Dental Inc. |
The Panthera Anti-Snoring X3 Device |
02/22/2018 |
K181396 |
Passion for Life Healthcare (UK) Limited |
Oral Device OA, Oral Device S |
11/16/2018 |
K991209 |
PERL-RAD SLEEP DISORDER LAB |
ORAL SLEEP DISORDER AID |
09/22/1999 |
K011723 |
PI MEDICAL |
ANTI-SNORING DEVICE OR ASD |
12/18/2002 |
K012142 |
PRECISION DENTAL LABORATORIES, INC. |
THE QUIET SLEEPER |
10/04/2001 |
K211069 |
Prismatik Dentalcraft, Inc. |
EndSnorZ Sleep Appliance |
10/26/2021 |
K183270 |
Prismatik Dentalcraft, Inc. |
Silent Nite sl |
07/17/2019 |
K210694 |
Prismatik Dentalcraft, Inc. |
Silent Nite Sleep Appliance with the Glidewell Hinge |
06/16/2021 |
K221889 |
ProSomnus Sleep Technologies |
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring |
10/06/2022 |
K202529 |
ProSomnus Sleep Technologies, Inc. |
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring |
11/20/2020 |
K103004 |
RANIR LLC |
SNORE GUARD |
02/25/2011 |
K102118 |
RANIR LLC |
SNORE GUARD ADVANCE |
09/08/2010 |
K111207 |
RESPIRE MEDICAL |
RESPIRE BLUE SERIES |
08/23/2011 |
K131138 |
RESPIRE MEDICAL |
RESPIRE PINK SERIES - HERBST |
09/09/2013 |
K152292 |
Respire Medical Holding |
Respire Blue Series-EF |
12/07/2015 |
K170692 |
Respire Medical Holding |
Respire Pink Series with DentiTrac |
05/26/2017 |
K150572 |
Respire Medical Holding |
Respire Pink Series-Herbst-EF |
08/27/2015 |
K192127 |
Respire Medical Holdings |
Respire Pink AT (Hard, Hard/Soft, EF) |
02/05/2020 |
K214096 |
Respire Medical, LLC |
Respire Clear |
05/31/2022 |
K033822 |
RESPIRONICS, INC. |
RESPIRONICS CUSTOM I ORAL APPLIANCE |
02/06/2004 |
K033823 |
RESPIRONICS, INC. |
RESPIRONICS CUSTOM II ORAL APPLIANCE |
02/06/2004 |
K040417 |
RESTORE MEDICAL INC. |
PILLAR PALATAL IMPLANT SYSTEM |
07/28/2004 |
K121344 |
RH ASSOCIATES LLC |
NU SLEEP |
10/17/2012 |
K042161 |
RJ & VK BIRD PTY LTD. |
ANTI-SNORING/SLEEP APNEA DEVICE |
10/27/2004 |
K210636 |
S4S UK Ltd. |
Morpheus |
02/15/2022 |
K150566 |
SAS Oniris |
Oniris |
03/21/2016 |
K171529 |
Scope Healthcare Technologies Pty Ltd |
Snorer's Friend |
01/02/2018 |
K955336 |
SCOTT FELDMAN DDS & NORMAN SHAPIRO DDS |
SNOREFREE |
01/04/1996 |
K220688 |
Shinrin-Yoku Traders LLC |
SilentZPro 2.0 |
12/02/2022 |
K153291 |
SICAT GMBH & CO. KG |
SICAT OPTISLEEP |
03/31/2016 |
K182661 |
Sketchpad Innovations LLC |
Kava and Kava with Herbst |
02/13/2019 |
K100185 |
SLEEP MEDICINE NETWORK, INC. |
SLEEP APP |
11/19/2010 |
K113022 |
SLEEP SCIENCE PARTNERS, INC. |
PURESLEEP |
06/11/2012 |
K190058 |
Sleep Science Partners, Inc. |
PureSleep (OTC use) |
04/11/2019 |
K213088 |
Sleeping Well, LLC |
ZQuiet Advance |
06/15/2022 |
K090503 |
SLEEPING WELL, LLC |
ZQUIET MOUTHPIECE |
03/10/2009 |
K093407 |
SLEEPING WELL, LLC |
ZQUIET MOUTHPIECE |
06/22/2010 |
K122475 |
SLEEPING WELL, LLC |
ZQUIET PRO-PLUS |
12/07/2012 |
K140777 |
SLEEPING WELL, LLC |
ZQUIET-SA |
07/25/2014 |
K180124 |
Sleeping Well,LLC |
ZQuiet |
06/12/2018 |
K101155 |
SLEEPWRIGHT |
AURADORM (NEUROMUSCULAR SLEEP) |
05/12/2011 |
K200657 |
SmartGuard Rx Inc. |
SmartGuard Anti-Snoring Device |
08/23/2021 |
K991948 |
SNORE - EZZER |
DR. B'S MOUTHPIECE, MODEL 32129-10002 |
09/02/1999 |
K974531 |
SNORE - EZZER |
SNORE-EZZER |
02/12/1998 |
K210910 |
SnoreBandit LLC |
Snore Bandit |
07/01/2021 |
K222475 |
Solbaro Co., Ltd |
SNOR LOCK |
11/10/2022 |
K152660 |
Somnics Inc. |
HYPNOSPAD |
11/09/2016 |
K102521 |
SOMNOMED INC. |
PANTINO PRO POSITINER |
03/28/2011 |
K162306 |
SomnoMed Inc. |
SomnoDent ALPHA |
09/20/2016 |
K183443 |
SomnoMed Inc. |
SomnoDent Avant |
05/08/2019 |
K140278 |
SOMNOMED INC. |
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX |
06/20/2014 |
K121340 |
SOMNOMED INC. |
SOMNODENT G2 |
05/30/2012 |
K130558 |
SOMNOMED INC. |
SOMNODENT HERBST; CLASSIC, FLEX |
05/17/2013 |
K073004 |
SOMNOMED INC. |
SOMNOMED BFLEX |
01/30/2008 |
K050592 |
SOMNOMED LTD |
SOMNOMED MAS RXA |
07/12/2005 |
K150941 |
Somnowell Ltd. |
Somnowell Mandibular Advancement Appliance (MAA) |
05/22/2015 |
K083209 |
SPECIALTY APPLIANCE WORKS, INC. |
ACRYLIC HERBST SPLINT APPLIANCE |
01/27/2009 |
K190687 |
Stephen J Harkins, DDS, PC |
Twilite Appliance |
07/02/2019 |
K101709 |
STEVEN B. LAMBERG, DDS |
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) |
08/18/2010 |
K013687 |
STEVEN K. SUE |
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER |
05/28/2002 |
K062333 |
STEVEN LAMBERG, D.D.S |
LAIMAD |
12/14/2006 |
K060795 |
STRATEGIC COUNSEL SARL |
SOMNOFIT |
12/18/2006 |
K023836 |
STRONG DENTAL INC. |
THE SUAD DEVICE |
07/08/2003 |
K070327 |
SYBRON DENTAL SPECIALTIES, INC. |
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR |
05/25/2007 |
K170053 |
The Center for Craniofacial & Dental Sleep Medicine |
Meridian PM |
11/28/2017 |
K981923 |
THE SNORE PEACE GROUP |
THE SNORE PEACE |
08/24/1998 |
K092942 |
THE SNORE RELIEVER COMPANY LLC |
VITAL SLEEP |
01/13/2010 |
K201719 |
The Snore Reliever Company, LLC |
Vital Sleep |
01/14/2021 |
K222127 |
The TMJ Clinic, PC. |
Soft Palate Elevator |
10/24/2022 |
K061688 |
TOMED DR. TOUSSAINT GMBH |
ANTI-SNORING / SLEEP APNEA DEVICE |
09/08/2006 |
K121761 |
TOMED DR. TOUSSAINT GMBH |
SOMNOGUARD SP SOFT |
09/28/2012 |
K170578 |
True Function Laboratory, Inc. |
True Function Adjustable Herbst Appliances |
11/24/2017 |
K180691 |
True Function Laboratory, Inc. |
TrueDorsal Devices |
02/11/2019 |
K955822 |
UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS |
REMOVABLE HERBST APPLIANCE |
03/20/1996 |
K993381 |
UNIVERSITY OF OTAGO |
TONGUE STABILIZER DEVICE |
12/21/1999 |
K222872 |
Vivos Therapeutics, Inc. |
DNA Appliance |
12/30/2022 |
K210203 |
Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) |
mmRNA appliance |
08/19/2021 |
K972061 |
W. KEITH THORNTON, D.D.S. |
TOA |
08/21/1997 |
K213475 |
Zelegent, Inc. |
Elevo Snoring Intervention Set |
01/27/2022 |
K181107 |
Zelegent, Inc. |
Elevo« Kit Snoring Intervention Device |
12/06/2018 |
K103704 |
ZEPHYR SLEEP TECHNOLOGIES INC |
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP |
03/23/2012 |
K190051 |
Zephyr Sleep Technologies, Inc. |
TD Clip |
06/07/2019 |