Device, Anti-Snoring
Regulation 872.5570
14510(k)s in 12 months (217 all time)
2recalls in 12 months (10 all time)
6recalls that name a 510(k)
Top companies in LRK
| Company | 510(k)s | Recalls |
|---|---|---|
| Somnomed, Inc. | 9 | 0 |
| Respire Medical | 3 | 5 |
| Sleeping Well, LLC | 6 | 0 |
| Prismatik Dentalcraft, Inc. | 4 | 1 |
| Airway Management, Inc. | 4 | 0 |
| Allen J. Moses, Dds, Ltd. | 4 | 0 |
| Always More Marketing | 4 | 0 |
| Medtronic Xomed, Inc. | 2 | 2 |
| Oventus Manufacturing Pty, Ltd. | 4 | 0 |
| Dental Imagineers, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2010 | K093407 | ZQUIET MOUTHPIECE Sleeping Well, LLC | LRK |
| Jun 11, 2010 | K093340 | PASR/QUIETNITE Exact Supplies , Ltd., GB | LRK |
| May 12, 2010 | K093710 | THE MOSES APPLIANCE Allen J. Moses, Dds, Ltd. | LRK |
| Apr 16, 2010 | K090436 | AIRWAYEASE MAS Orthoplant Dental Lab, AU | LRK |
| Jan 13, 2010 | K092942 | VITAL SLEEP The Snore Reliever Company, LLC | LRK |
| Jul 16, 2009 | K082849 | SILENT SLEEP Craniofacial Pain Center of Idaho | LRK |
| Mar 10, 2009 | K090503 | ZQUIET MOUTHPIECE Sleeping Well, LLC | LRK |
| Jan 27, 2009 | K083209 | ACRYLIC HERBST SPLINT APPLIANCE Specialty Appliance Works, Inc. | LRK |
| Oct 27, 2008 | K081965 | MPOWRX SNORING SOLUTION Mpowrx Health and Wellness Products, Inc. | LRK |
| Jun 12, 2008 | K072731 | ENDSNOR Dockstader Orthodontic Lab, Inc. | LRK |
| Jan 30, 2008 | K073004 | SOMNOMED BFLEX Somnomed, Inc. | LRK |
| May 25, 2007 | K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR Sybron Dental Specialties, Inc. | LRK |
| Dec 18, 2006 | K060795 | SOMNOFIT Strategic Counsel Sarl | LRK |
| Dec 14, 2006 | K062333 | LAIMAD Steven Lamberg, D.D.S | LRK |
| Dec 12, 2006 | K062951 | TAP III ANTI-SNORING DEVICE Airway Management, Inc. | LRK |
| Sep 8, 2006 | K061688 | ANTI-SNORING / SLEEP APNEA DEVICE Tomed Dr. Toussaint GmbH, DE | LRK |
| Jul 12, 2006 | K061732 | TAP-T Airway Management, Inc. | LRK |
| Jun 2, 2006 | K060744 | O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) O'Brien Dental Lab, Inc. | LRK |
| May 19, 2006 | K060122 | SLEEP SPLINT Nakagawa Dental Clinic | LRK |
| May 17, 2006 | K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT Airway Management, Inc. | LRK |
| Aug 9, 2005 | K051014 | SILENT PARTNER SERIES OSA APPLIANCES Dreamwrx Dental Laboratory | LRK |
| Jul 12, 2005 | K050592 | SOMNOMED MAS RXA Somnomed, Ltd. | LRK |
| May 3, 2005 | K041184 | NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION Nti-Tss, Inc. | LRK |
| Oct 27, 2004 | K042161 | ANTI-SNORING/SLEEP APNEA DEVICE Rj & VK Bird Pty , Ltd., AU | LRK |
| Jul 28, 2004 | K040417 | PILLAR PALATAL IMPLANT SYSTEM Restore Medical, Inc. | LRK |
| Mar 15, 2004 | K021569 | RESTFUL NIGHTS, IST-APPLIANCE Ottawa Dental Laboratory | LRK |
| Feb 6, 2004 | K033823 | RESPIRONICS CUSTOM II ORAL APPLIANCE Respironics, Inc. | LRK |
| Feb 6, 2004 | K033822 | RESPIRONICS CUSTOM I ORAL APPLIANCE Respironics, Inc. | LRK |
| Aug 26, 2003 | K030440 | OASYS-ORAL AIRWAY SYSTEM Mark Abramson, D.D.S., Inc. | LRK |
| Jul 8, 2003 | K023836 | THE SUAD DEVICE Strong Dental, Inc. | LRK |
| Feb 19, 2003 | K022891 | THE BREATHE EZ ANTI-SNORING DEVICE D&S Redhage | LRK |
| Dec 18, 2002 | K011723 | ANTI-SNORING DEVICE OR ASD Pi Medical | LRK |
| Dec 10, 2002 | K022284 | SNORE-AID MAX Dental Imagineers, LLC | LRK |
| May 28, 2002 | K020893 | NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE Dennis R. Bailey, Dds | LRK |
| May 28, 2002 | K013687 | NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER Steven K. Sue | LRK |
| Jan 30, 2002 | K013808 | SLEEPBITE Dental Imagineers, LLC | LRK |
| Nov 29, 2001 | K013049 | NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE Dennis R. Bailey, Dds | LRK |
| Oct 4, 2001 | K012142 | THE QUIET SLEEPER Precision Dental Laboratories, Inc. | LRK |
| Dec 21, 1999 | K993381 | TONGUE STABILIZER DEVICE University of Otago | LRK |
| Sep 22, 1999 | K991209 | ORAL SLEEP DISORDER AID Perl-Rad Sleep Disorder Lab | LRK |
| Sep 2, 1999 | K991948 | DR. B'S MOUTHPIECE, MODEL 32129-10002 Snore - Ezzer | LRK |
| Aug 27, 1999 | K981677 | REPOSE BONE SCREW SYSTEM Influence, Inc. | LRK |
| Jul 22, 1999 | K991449 | SNORE-AID PLUS Dental Imagineers, LLC | LRK |
| Aug 24, 1998 | K981923 | THE SNORE PEACE The Snore Peace Group | LRK |
| Jun 1, 1998 | K980952 | SNORE-CURE ANTI-SNORING APPLIANCE ORTHO-TAIN, Inc. | LRK |
| Feb 12, 1998 | K974531 | SNORE-EZZER Snore - Ezzer | LRK |
| Jan 9, 1998 | K973884 | ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE Frantz Design, Inc. | LRK |
| Jan 9, 1998 | K963591 | SNORING CONTROL DEVICE Kenneth Hilsen | LRK |
| Nov 12, 1997 | K973038 | ADJUSTABLE THERASNORE Distar, Inc. | LRK |
| Sep 29, 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE Frantz Design, Inc. | LRK |
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