Device, Anti-Snoring
The Anti-Snoring Device is a dental appliance designed to reposition the mandible or maintain airway patency during sleep to reduce or eliminate snoring, typically through oral repositioning mechanisms. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRK, regulated under 21 CFR 872.5570, within the Dental medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
Basic Information
- Product Code
- LRK
- Device Class
- FDA class 2
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 213 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261366 | Virtus | Jun 12, 2026 | Substantially Equivalent | Somnomed, Inc. |
| K261251 | Snorbliss® Anti-Snoring Device | Jun 11, 2026 | Substantially Equivalent | Endeavor Commerce, LLC |
| K261134 | Dormiva Anti-Snoring Mouth Guard | May 14, 2026 | Substantially Equivalent | Koncept Innovators, Inc. |
| K252942 | ShaeferH | Apr 10, 2026 | Substantially Equivalent | Shaeferh, LLC |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Mar 03, 2026 | Substantially Equivalent | Ram.Shaw Pte. , Ltd. |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Mar 02, 2026 | Substantially Equivalent | Myofunctional Research Co. |
| K252976 | Park Dental Nylon MAD | Dec 18, 2025 | Substantially Equivalent | Park Dental Research Corp. |
| K253868 | QuietLab Pro | Dec 05, 2025 | Substantially Equivalent | QuietLab, LLC |
| K252161 | Hushd Avera | Nov 25, 2025 | Substantially Equivalent | Good Sleep CO Pte , Ltd. |
| K252525 | AIO Breathe | Nov 06, 2025 | Substantially Equivalent | Aiomega, LLC |
| K252698 | NightGuard Aire Max | Nov 03, 2025 | Substantially Equivalent | Nightguard Express, LLC |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Oct 29, 2025 | Substantially Equivalent | Fissiontech, LLC |
| K251784 | Hushd Pro Z-Link | Oct 24, 2025 | Substantially Equivalent | Good Sleep CO Pte , Ltd. |
| K251628 | Mandibular Advancement Device L07 | Oct 22, 2025 | Substantially Equivalent | Dcstar, Inc. |
| K250028 | Anti Snore Mouthpiece | Oct 03, 2025 | Substantially Equivalent | Dongguan Yiyao Science & Technology Development Co., Ltd. |
| K243752 | Double Tube Herbst Appliance | Sep 17, 2025 | Substantially Equivalent | The Tmj Clinic PC |
| K252374 | Nylon flexTAP(R) | Sep 11, 2025 | Substantially Equivalent | Airway Technologies D/B/A Airway Management |
| K250353 | Oniris; Oniris Plus | Sep 04, 2025 | Substantially Equivalent | Oniris |
| K250122 | SleepRight Snore Aid | May 19, 2025 | Substantially Equivalent | Splintek, Inc. |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | May 08, 2025 | Substantially Equivalent | Fissiontech, LLC |
| K234089 | DNA Appliance | Sep 16, 2024 | Substantially Equivalent | Vivos Therapeutics |
| K232025 | Hushd Pro Avera | May 09, 2024 | Substantially Equivalent | Good Sleep CO Pte , Ltd. |
| K232735 | EMA 3D | May 03, 2024 | Substantially Equivalent | Ema Sleep Incorporated |
| K233850 | Difiney Anti Snoring Device | Apr 18, 2024 | Substantially Equivalent | Fissiontech, LLC |
| K240427 | airVata | Feb 14, 2024 | Substantially Equivalent | Gelb Practice Solutions, Inc. |
| K231138 | Aniti-Snore Mouthguard+ | Jan 16, 2024 | Substantially Equivalent | Oscimed SA |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Nov 28, 2023 | Substantially Equivalent | Vivos Therapeutics, Inc. |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Nov 14, 2023 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Sep 18, 2023 | Substantially Equivalent | Innovative Health Technologies (Nz), Ltd. |
| K223901 | ApneaRX Pro | Sep 01, 2023 | Substantially Equivalent | Apnea Sciences Coporation |
| K223624 | Emerald Herbst | May 10, 2023 | Substantially Equivalent | Island Dental Lab, Inc Dba Emerald Dental |
| K222872 | DNA Appliance | Dec 30, 2022 | Substantially Equivalent | Vivos Therapeutics, Inc. |
| K220688 | SilentZPro 2.0 | Dec 02, 2022 | Substantially Equivalent | Shinrin-Yoku Traders, LLC |
| K222475 | SNOR LOCK | Nov 10, 2022 | Substantially Equivalent | Solbaro Co., Ltd. |
| K221322 | CUSTMBITE Snoring System | Oct 27, 2022 | Substantially Equivalent | Dental Choice Holdings, LLC |
| K222127 | Soft Palate Elevator | Oct 24, 2022 | Substantially Equivalent | The Tmj Clinic PC |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | Oct 06, 2022 | Substantially Equivalent | Prosomnus Sleep Technologies |
| K220330 | Soundly Anti Snoring Device | Sep 08, 2022 | Substantially Equivalent | Greystone Ip, Ltd. |
| K213088 | ZQuiet Advance | Jun 15, 2022 | Substantially Equivalent | Sleeping Well, LLC |
| K214096 | Respire Clear | May 31, 2022 | Substantially Equivalent | Respire Medical, LLC |
| K210636 | Morpheus | Feb 15, 2022 | Substantially Equivalent | S4S UK , Ltd. |
| K213475 | Elevo Snoring Intervention Set | Jan 27, 2022 | Substantially Equivalent | Zelegent, Inc. |
| K211069 | EndSnorZ Sleep Appliance | Oct 26, 2021 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K200657 | SmartGuard Anti-Snoring Device | Aug 23, 2021 | Substantially Equivalent | Smartguard Rx, Inc. |
| K210203 | mmRNA appliance | Aug 19, 2021 | Substantially Equivalent | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) |
| K210910 | Snore Bandit | Jul 01, 2021 | Substantially Equivalent | Snorebandit, LLC |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Jun 16, 2021 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Mar 10, 2021 | Substantially Equivalent | Meris Investment Group |
| K203477 | Classic | Feb 25, 2021 | Substantially Equivalent | Orthoapnea S.L. |
| K203462 | Advanced Dental Appliance | Feb 19, 2021 | Substantially Equivalent | Dasoft Partners |
| K202651 | NOA Sleep Apnea and Snoring Device | Feb 12, 2021 | Substantially Equivalent | Orthoapnea S.L. |
| K201719 | Vital Sleep | Jan 14, 2021 | Substantially Equivalent | The Snore Reliever Company, LLC |
| K201484 | Somnos Anti-Snoring Mouth Guard | Nov 23, 2020 | Substantially Equivalent | Koncept Innovators, LLC |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | Nov 20, 2020 | Substantially Equivalent | Prosomnus Sleep Technologies, Inc. |
| K202499 | Diamond Digital Sleep Orthotic (DDSO) | Sep 03, 2020 | Substantially Equivalent | Diamond Orthotic Laboratory |
| K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Feb 05, 2020 | Substantially Equivalent | Respire Medical Holdings |
| K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution) | Jan 03, 2020 | Substantially Equivalent | Mpowrx Health and Wellness Products 2012, Inc. |
| K191618 | SleepTight Mouthpiece STZ | Dec 11, 2019 | Substantially Equivalent | Michael D Williams Dds PA |
| K181416 | Sapphire Dorsal Comfort Fit | Sep 17, 2019 | Substantially Equivalent | Crane Dental Laboratory, Inc. |
| K190236 | O2Vent Optima | Aug 29, 2019 | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. |
| K183270 | Silent Nite sl | Jul 17, 2019 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K190687 | Twilite Appliance | Jul 02, 2019 | Substantially Equivalent | Stephen J Harkins, Dds, PC |
| K190051 | TD Clip | Jun 07, 2019 | Substantially Equivalent | Zephyr Sleep Technologies, Inc. |
| K183443 | SomnoDent Avant | May 08, 2019 | Substantially Equivalent | Somnomed, Inc. |
| K190058 | PureSleep (OTC use) | Apr 11, 2019 | Substantially Equivalent | Sleep Science Partners, Inc. |
| K173064 | ZAPnea Oral Appliance | Mar 08, 2019 | Substantially Equivalent | B. Fareid, Dds, PC |
| K182661 | Kava and Kava with Herbst | Feb 13, 2019 | Substantially Equivalent | Sketchpad Innovations, LLC |
| K180691 | TrueDorsal Devices | Feb 11, 2019 | Substantially Equivalent | True Function Laboratory, Inc. |
| K182312 | Zyppah Anti-Snoring Device | Jan 24, 2019 | Substantially Equivalent | Always More Marketing |
| K182202 | SLEEPAPP | Jan 11, 2019 | Substantially Equivalent | Comfort Acrylics, Inc. |
| K181107 | Elevo® Kit Snoring Intervention Device | Dec 06, 2018 | Substantially Equivalent | Zelegent, Inc. |
| K181123 | ApnoDent Appliance | Nov 21, 2018 | Substantially Equivalent | Apnomed, Inc. |
| K181396 | Oral Device OA, Oral Device S | Nov 16, 2018 | Substantially Equivalent | Passion For Life Healthcare (Uk) Limited |
| K181482 | myTAP2 | Aug 31, 2018 | Substantially Equivalent | Airway Management, Inc. |
| K172991 | Advanced Dental Applicance | Jul 10, 2018 | Substantially Equivalent | Dasoft Partners |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance | Jun 26, 2018 | Substantially Equivalent | Moses Appliances, LLC |
| K180124 | ZQuiet | Jun 12, 2018 | Substantially Equivalent | Sleeping Well, LLC |
| K172760 | REST EAZY Appliance | Mar 26, 2018 | Substantially Equivalent | Insert Molding Solutions, Inc. |
| K171576 | The Panthera Anti-Snoring X3 Device | Feb 22, 2018 | Substantially Equivalent | Panthera Dental, Inc. |
| K171529 | Snorer's Friend | Jan 02, 2018 | Substantially Equivalent | Scope Healthcare Technologies Pty, Ltd. |
| K170053 | Meridian PM | Nov 28, 2017 | Substantially Equivalent | The Center For Craniofacial & Dental Sleep Medicine |
| K170578 | True Function Adjustable Herbst Appliances | Nov 24, 2017 | Substantially Equivalent | True Function Laboratory, Inc. |
| K170825 | SnoreRx | Aug 18, 2017 | Substantially Equivalent | Apnea Sciences Corporation |
| K171316 | O2Vent W | Jul 11, 2017 | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. |
| K163580 | ASD Oral Appliances | Jun 08, 2017 | Substantially Equivalent | American Sleep Dentistry |
| K170692 | Respire Pink Series with DentiTrac | May 26, 2017 | Substantially Equivalent | Respire Medical Holding |
| K161980 | Fuselier Intraoral Nighttime Device (FIND) | Feb 07, 2017 | Substantially Equivalent | Fuselier Enterprises, LLC |
| K162192 | BluePro | Dec 15, 2016 | Substantially Equivalent | Bluesom |
| K152660 | HYPNOSPAD | Nov 09, 2016 | Substantially Equivalent | Somnics, Inc. |
| K161832 | O2VENT T | Sep 23, 2016 | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. |
| K162306 | SomnoDent ALPHA | Sep 20, 2016 | Substantially Equivalent | Somnomed, Inc. |
| K160531 | Noiselezz | Sep 01, 2016 | Substantially Equivalent | Firma Ingemarsson |
| K153200 | SnoreRx | Aug 09, 2016 | Substantially Equivalent | Apnea Sciences Corporation |
| K160123 | Apinator | Jul 12, 2016 | Substantially Equivalent | Allen J. Moses, Dds, Ltd. |
| K153291 | SICAT OPTISLEEP | Mar 31, 2016 | Substantially Equivalent | Sicat GmbH & Co. KG |
| K150566 | Oniris | Mar 21, 2016 | Substantially Equivalent | Sas Oniris |
| K160234 | OVENT | Mar 17, 2016 | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. |
| K152292 | Respire Blue Series-EF | Dec 07, 2015 | Substantially Equivalent | Respire Medical Holding |
| K152159 | Oravan Herbst | Oct 29, 2015 | Substantially Equivalent | Oravanosa, LLC |
| K150572 | Respire Pink Series-Herbst-EF | Aug 27, 2015 | Substantially Equivalent | Respire Medical Holding |
| K142651 | The Moses Express appliance | Jul 17, 2015 | Substantially Equivalent | Allen J. Moses, Dds, Ltd. |
| K150941 | Somnowell Mandibular Advancement Appliance (MAA) | May 22, 2015 | Substantially Equivalent | Somnowell , Ltd. |
| K143591 | Dorsal Appliance | Apr 15, 2015 | Substantially Equivalent | Gergens Orthodontic Lab |
| K143244 | The Panthera Anti-Snoring Device | Dec 15, 2014 | Substantially Equivalent | Panthera Dental, Inc. |
| K140663 | THERASNORE | Dec 12, 2014 | Substantially Equivalent | Distar, LLC |
| K133390 | NDX DORSAL APPLIANCE | Oct 16, 2014 | Substantially Equivalent | Institute For Quality Resource Management |
| K140429 | CRANE ACRYLIC HERBST APPLIANCE | Sep 11, 2014 | Substantially Equivalent | Crane Dental Laboratory, Inc. |
| K140777 | ZQUIET-SA | Jul 25, 2014 | Substantially Equivalent | Sleeping Well, LLC |
| K133683 | MICR02 OSA DEVICE | Jul 24, 2014 | Substantially Equivalent | Microdental, Inc. |
| K140435 | MEDLEY GOLD | Jun 26, 2014 | Substantially Equivalent | American Dental Sleep Medicine, Ip, LLC |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | Jun 20, 2014 | Substantially Equivalent | Somnomed, Inc. |
| K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY | May 29, 2014 | Substantially Equivalent | Michael D Williams Dds PA |
| K130067 | MRNA APPLIANCE | May 08, 2014 | Substantially Equivalent | Biomodeling Solutions, Lls |
| K132933 | THE MOSES ELITE APPLIANCE | Apr 25, 2014 | Substantially Equivalent | Allen J. Moses, Dds, Ltd. |
| K130797 | LUCO HYBRID OSA APPLIANCE | Dec 18, 2013 | Substantially Equivalent | Luco Hybrid Osa Appliance, Inc. |
| K130504 | ASA ORAL APPLIANCES | Oct 18, 2013 | Substantially Equivalent | American Sleep Association |
| K131138 | RESPIRE PINK SERIES - HERBST | Sep 09, 2013 | Substantially Equivalent | Respire Medical |
| K113126 | ACRYLIC HERBST APPLIANCE | Jul 17, 2013 | Substantially Equivalent | Gergens Orthodontic Lab |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | May 17, 2013 | Substantially Equivalent | Somnomed, Inc. |
| K123410 | HEALTHY SLEEP APPLIANCE | Apr 05, 2013 | Substantially Equivalent | Healthy Sleep Dental Laboratory |
| K121285 | ORAVAN OSA | Mar 08, 2013 | Substantially Equivalent | New Jersey Snoring Solutions |
| K122391 | MEDTRONIC XOMED, INC. | Jan 10, 2013 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K113516 | THERASOM-CAST | Jan 04, 2013 | Substantially Equivalent | Family Dental Services, P.C. |
| K122475 | ZQUIET PRO-PLUS | Dec 07, 2012 | Substantially Equivalent | Sleeping Well, LLC |
| K121344 | NU SLEEP | Oct 17, 2012 | Substantially Equivalent | Rh Associates, LLC |
| K121761 | SOMNOGUARD SP SOFT | Sep 28, 2012 | Substantially Equivalent | Tomed Dr. Toussaint GmbH |
| K120372 | DR GREENBURGS HYBRID VACUUM | Jun 27, 2012 | Substantially Equivalent | Always More Marketing, Inc. |
| K120371 | DR GREENBURGS HYBRID ACRYLIC | Jun 27, 2012 | Substantially Equivalent | Always More Marketing, Inc. |
| K113022 | PURESLEEP | Jun 11, 2012 | Substantially Equivalent | Sleep Science Partners, Inc. |
| K121340 | SOMNODENT G2 | May 30, 2012 | Substantially Equivalent | Somnomed, Inc. |
| K103704 | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP | Mar 23, 2012 | Substantially Equivalent | Zephyr Sleep Technologies, Inc. |
| K113569 | APNEARX | Mar 01, 2012 | Substantially Equivalent | Apnea Science Corporation |
| K110623 | PILLAR PALATAL IMPLANT SYSTEM | Feb 10, 2012 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K111680 | DR. GREENSBURG'S HYBRID | Dec 23, 2011 | Substantially Equivalent | Always More Marketing, Inc. |
| K112205 | SNORERX 9.0 | Nov 16, 2011 | Substantially Equivalent | Consumer Health Products, Inc. |
| K111207 | RESPIRE BLUE SERIES | Aug 23, 2011 | Substantially Equivalent | Respire Medical |
| K111110 | APNEA GUARD | Jul 22, 2011 | Substantially Equivalent | Advanced Brain Monitoring, Inc. |
| K111009 | ACRYLIC HERBST APPLIANCE | Jul 22, 2011 | Substantially Equivalent | Embassy Dental Laboratory |
| K102463 | GOOD NIGHT | May 25, 2011 | Substantially Equivalent | Larry V Connell, Dmd |
| K101155 | AURADORM (NEUROMUSCULAR SLEEP) | May 12, 2011 | Substantially Equivalent | Sleepwright |
| K102521 | PANTINO PRO POSITINER | Mar 28, 2011 | Substantially Equivalent | Somnomed, Inc. |
| K103004 | SNORE GUARD | Feb 25, 2011 | Substantially Equivalent | Ranir, LLC |
| K103076 | DYNAFLEX | Feb 23, 2011 | Substantially Equivalent | Dyna Flex |
| K100185 | SLEEP APP | Nov 19, 2010 | Substantially Equivalent | Sleep Medicine Network, Inc. |
| K102118 | SNORE GUARD ADVANCE | Sep 08, 2010 | Substantially Equivalent | Ranir, LLC |
| K101709 | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) | Aug 18, 2010 | Substantially Equivalent | Steven B. Lamberg, Dds |
| K093407 | ZQUIET MOUTHPIECE | Jun 22, 2010 | Substantially Equivalent | Sleeping Well, LLC |
| K093340 | PASR/QUIETNITE | Jun 11, 2010 | Substantially Equivalent | Exact Supplies , Ltd. |
| K093710 | THE MOSES APPLIANCE | May 12, 2010 | Substantially Equivalent | Allen J. Moses, Dds, Ltd. |
| K090436 | AIRWAYEASE MAS | Apr 16, 2010 | Substantially Equivalent | Orthoplant Dental Lab |
| K092942 | VITAL SLEEP | Jan 13, 2010 | Substantially Equivalent | The Snore Reliever Company, LLC |
| K082849 | SILENT SLEEP | Jul 16, 2009 | Substantially Equivalent | Craniofacial Pain Center of Idaho |
| K090503 | ZQUIET MOUTHPIECE | Mar 10, 2009 | Substantially Equivalent | Sleeping Well, LLC |
| K083209 | ACRYLIC HERBST SPLINT APPLIANCE | Jan 27, 2009 | Substantially Equivalent | Specialty Appliance Works, Inc. |
| K081965 | MPOWRX SNORING SOLUTION | Oct 27, 2008 | Substantially Equivalent | Mpowrx Health and Wellness Products, Inc. |
| K072731 | ENDSNOR | Jun 12, 2008 | Substantially Equivalent | Dockstader Orthodontic Lab, Inc. |
| K073004 | SOMNOMED BFLEX | Jan 30, 2008 | Substantially Equivalent | Somnomed, Inc. |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | May 25, 2007 | Substantially Equivalent | Sybron Dental Specialties, Inc. |
| K060795 | SOMNOFIT | Dec 18, 2006 | Substantially Equivalent | Strategic Counsel Sarl |
| K062333 | LAIMAD | Dec 14, 2006 | Substantially Equivalent | Steven Lamberg, D.D.S |
| K062951 | TAP III ANTI-SNORING DEVICE | Dec 12, 2006 | Substantially Equivalent | Airway Management, Inc. |
| K061688 | ANTI-SNORING / SLEEP APNEA DEVICE | Sep 08, 2006 | Substantially Equivalent | Tomed Dr. Toussaint GmbH |
| K061732 | TAP-T | Jul 12, 2006 | Substantially Equivalent | Airway Management, Inc. |
| K060744 | O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) | Jun 02, 2006 | Substantially Equivalent | O'Brien Dental Lab, Inc. |
| K060122 | SLEEP SPLINT | May 19, 2006 | Substantially Equivalent | Nakagawa Dental Clinic |
| K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT | May 17, 2006 | Substantially Equivalent | Airway Management, Inc. |
| K051014 | SILENT PARTNER SERIES OSA APPLIANCES | Aug 09, 2005 | Substantially Equivalent | Dreamwrx Dental Laboratory |
| K050592 | SOMNOMED MAS RXA | Jul 12, 2005 | Substantially Equivalent | Somnomed, Ltd. |
| K041184 | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION | May 03, 2005 | Substantially Equivalent | Nti-Tss, Inc. |
| K042161 | ANTI-SNORING/SLEEP APNEA DEVICE | Oct 27, 2004 | Substantially Equivalent | Rj & VK Bird Pty , Ltd. |
| K040417 | PILLAR PALATAL IMPLANT SYSTEM | Jul 28, 2004 | Substantially Equivalent | Restore Medical, Inc. |
| K021569 | RESTFUL NIGHTS, IST-APPLIANCE | Mar 15, 2004 | Substantially Equivalent | Ottawa Dental Laboratory |
| K033823 | RESPIRONICS CUSTOM II ORAL APPLIANCE | Feb 06, 2004 | Substantially Equivalent | Respironics, Inc. |
| K033822 | RESPIRONICS CUSTOM I ORAL APPLIANCE | Feb 06, 2004 | Substantially Equivalent | Respironics, Inc. |
| K030440 | OASYS-ORAL AIRWAY SYSTEM | Aug 26, 2003 | Substantially Equivalent | Mark Abramson, D.D.S., Inc. |
| K023836 | THE SUAD DEVICE | Jul 08, 2003 | Substantially Equivalent | Strong Dental, Inc. |
| K022891 | THE BREATHE EZ ANTI-SNORING DEVICE | Feb 19, 2003 | Substantially Equivalent | D&S Redhage |
| K011723 | ANTI-SNORING DEVICE OR ASD | Dec 18, 2002 | Substantially Equivalent | Pi Medical |
| K022284 | SNORE-AID MAX | Dec 10, 2002 | Substantially Equivalent | Dental Imagineers, LLC |
| K020893 | NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | May 28, 2002 | Substantially Equivalent | Dennis R. Bailey, Dds |
| K013687 | NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER | May 28, 2002 | Substantially Equivalent | Steven K. Sue |
| K013808 | SLEEPBITE | Jan 30, 2002 | Substantially Equivalent | Dental Imagineers, LLC |
| K013049 | NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE | Nov 29, 2001 | Substantially Equivalent | Dennis R. Bailey, Dds |
| K012142 | THE QUIET SLEEPER | Oct 04, 2001 | Substantially Equivalent | Precision Dental Laboratories, Inc. |
| K993381 | TONGUE STABILIZER DEVICE | Dec 21, 1999 | Substantially Equivalent | University of Otago |
| K991209 | ORAL SLEEP DISORDER AID | Sep 22, 1999 | Substantially Equivalent | Perl-Rad Sleep Disorder Lab |
| K991948 | DR. B'S MOUTHPIECE, MODEL 32129-10002 | Sep 02, 1999 | Substantially Equivalent | Snore - Ezzer |
| K981677 | REPOSE BONE SCREW SYSTEM | Aug 27, 1999 | Substantially Equivalent | Influence, Inc. |
| K991449 | SNORE-AID PLUS | Jul 22, 1999 | Substantially Equivalent | Dental Imagineers, LLC |
| K981923 | THE SNORE PEACE | Aug 24, 1998 | Substantially Equivalent | The Snore Peace Group |
| K980952 | SNORE-CURE ANTI-SNORING APPLIANCE | Jun 01, 1998 | Substantially Equivalent | ORTHO-TAIN, Inc. |
| K974531 | SNORE-EZZER | Feb 12, 1998 | Substantially Equivalent | Snore - Ezzer |
| K973884 | ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE | Jan 09, 1998 | Substantially Equivalent | Frantz Design, Inc. |
| K963591 | SNORING CONTROL DEVICE | Jan 09, 1998 | Substantially Equivalent | Kenneth Hilsen |
| K973038 | ADJUSTABLE THERASNORE | Nov 12, 1997 | Substantially Equivalent | Distar, Inc. |
| K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | Sep 29, 1997 | Substantially Equivalent | Frantz Design, Inc. |
| K972424 | SILENTNITE | Sep 18, 1997 | Substantially Equivalent | Glidewell Laboratories |
| K972023 | SLEEP-IN BONE SCREW SYSTEM | Aug 25, 1997 | Substantially Equivalent | Influence, Inc. |
| K972061 | TOA | Aug 21, 1997 | Substantially Equivalent | W. Keith Thornton, D.D.S. |
| K963063 | SNORE TEC | Apr 14, 1997 | Substantially Equivalent | Marketing Technologies, Inc. |
| K964516 | TAP | Jan 24, 1997 | Substantially Equivalent | Nellcor Puritan Bennett, Inc. |
| K962516 | TAP ANTI-SNORING DEVICE | Sep 10, 1996 | Substantially Equivalent | Nellcor Puritan Bennett, Inc. |
| K955822 | REMOVABLE HERBST APPLIANCE | Mar 20, 1996 | Substantially Equivalent | Univ. Dental Assoc. Department of Orthodontics |
| K955336 | SNOREFREE | Jan 04, 1996 | Substantially Equivalent | Scott Feldman Dds & Norman Shapiro Dds |
| K954530 | THE SILENCER | Oct 30, 1995 | Substantially Equivalent | Silent Knights Ventures, Inc. |
| K954324 | SNOR-X MOUTH GUARD | Oct 17, 1995 | Substantially Equivalent | Snorex, Inc. |
| K954128 | SNOREMASTER | Oct 02, 1995 | Substantially Equivalent | D.D.S., Inc. |
| K950763 | LOWE KLEARWAY | May 25, 1995 | Substantially Equivalent | Dr. Alan A. Lowe, Inc. |
| K926382 | THERASNORE | Jul 08, 1993 | Substantially Equivalent | Dr. Thomas E. Meade |
| K922984 | ORTHODONTIC BITE | Mar 31, 1993 | Substantially Equivalent | American Orthodontics |
| K895189 | ADJUSTABLE SOFT PALATE LIFTER | Feb 09, 1990 | Substantially Equivalent | Ortho Publications, Inc. |
| K882303 | H&M ANTI-SNORING DEVICE | Apr 14, 1989 | Substantially Equivalent | Hays & Meade, Inc. |
| K874416 | DENTAL ANTI-SNORING DEVICE | Oct 18, 1988 | Substantially Equivalent | Ortho Publications, Inc. |
FEI Numbers
This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.