FDA 510(k) Applications for Medical Device Product Code "LRK"
(Device, Anti-Snoring)

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
K922984 AMERICAN ORTHODONTICS ORTHODONTIC BITE 03/31/1993
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
K153200 Apnea Sciences Corporation SnoreRx 08/09/2016
K170825 Apnea Sciences Corporation SnoreRx 08/18/2017
K181123 ApnoMed, Inc. ApnoDent Appliance 11/21/2018
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
K140429 CRANE DENTAL LABORATORY, INC. CRANE ACRYLIC HERBST APPLIANCE 09/11/2014
K082849 CRANIOFACIAL PAIN CENTER OF IDAHO SILENT SLEEP 07/16/2009
K954128 D D S, INC. SNOREMASTER 10/02/1995
K022891 D&S REDHAGE THE BREATHE EZ ANTI-SNORING DEVICE 02/19/2003
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
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
K973038 DISTAR, INC. ADJUSTABLE THERASNORE 11/12/1997
K140663 DISTAR, LLC THERASNORE 12/12/2014
K072731 DOCKSTADER ORTHODONTIC LAB, INC. ENDSNOR 06/12/2008
K950763 DR. ALAN A. LOWE, INC. LOWE KLEARWAY 05/25/1995
K926382 DR. THOMAS E. MEADE THERASNORE 07/08/1993
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
K971794 FRANTZ DESIGN, INC. ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE 09/29/1997
K973884 FRANTZ DESIGN, INC. ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE 01/09/1998
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
K882303 HAYS & MEADE, INC. H&M ANTI-SNORING DEVICE 04/14/1989
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
K172760 Insert Molding Solutions, Inc. REST EAZY Appliance 03/26/2018
K133390 INSTITUTE FOR QUALITY RESOURCE MANAGEMENT NDX DORSAL APPLIANCE 10/16/2014
K963591 KENNETH HILSEN SNORING CONTROL DEVICE 01/09/1998
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
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
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
K895189 ORTHO PUBLICATIONS, INC. ADJUSTABLE SOFT PALATE LIFTER 02/09/1990
K874416 ORTHO PUBLICATIONS, INC. DENTAL ANTI-SNORING DEVICE 10/18/1988
K980952 ORTHO-TAIN, INC. SNORE-CURE ANTI-SNORING APPLIANCE 06/01/1998
K090436 ORTHOPLANT DENTAL LAB AIRWAYEASE MAS 04/16/2010
K021569 OTTAWA DENTAL LABORATORY RESTFUL NIGHTS, IST-APPLIANCE 03/15/2004
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
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
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
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
K153291 SICAT GMBH & CO. KG SICAT OPTISLEEP 03/31/2016
K954530 SILENT KNIGHTS VENTURES, INC. THE SILENCER 10/30/1995
K100185 SLEEP MEDICINE NETWORK, INC. SLEEP APP 11/19/2010
K113022 SLEEP SCIENCE PARTNERS, INC. PURESLEEP 06/11/2012
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
K991948 SNORE - EZZER DR. B'S MOUTHPIECE, MODEL 32129-10002 09/02/1999
K974531 SNORE - EZZER SNORE-EZZER 02/12/1998
K954324 SNOREX, INC. SNOR-X MOUTH GUARD 10/17/1995
K152660 Somnics Inc. HYPNOSPAD 11/09/2016
K102521 SOMNOMED INC. PANTINO PRO POSITINER 03/28/2011
K162306 SomnoMed Inc. SomnoDent ALPHA 09/20/2016
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
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
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
K955822 UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS REMOVABLE HERBST APPLIANCE 03/20/1996
K993381 UNIVERSITY OF OTAGO TONGUE STABILIZER DEVICE 12/21/1999
K972061 W. KEITH THORNTON, D.D.S. TOA 08/21/1997
K181107 Zelegent, Inc. Elevo« Kit Snoring Intervention Device 12/06/2018
K103704 ZEPHYR SLEEP TECHNOLOGIES INC REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP 03/23/2012


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