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 |
|---|---|---|---|
| Mar 17, 2016 | K160234 | OVENT Oventus Manufacturing Pty, Ltd., AU | LRK |
| Dec 7, 2015 | K152292 | Respire Blue Series-EF Respire Medical Holding | LRK |
| Oct 29, 2015 | K152159 | Oravan Herbst Oravanosa, LLC | LRK |
| Aug 27, 2015 | K150572 | Respire Pink Series-Herbst-EF Respire Medical Holding | LRK |
| Jul 17, 2015 | K142651 | The Moses Express appliance Allen J. Moses, Dds, Ltd. | LRK |
| May 22, 2015 | K150941 | Somnowell Mandibular Advancement Appliance (MAA) Somnowell , Ltd., GB | LRK |
| Apr 15, 2015 | K143591 | Dorsal Appliance Gergens Orthodontic Lab | LRK |
| Dec 15, 2014 | K143244 | The Panthera Anti-Snoring Device Panthera Dental, Inc., CA | LRK |
| Dec 12, 2014 | K140663 | THERASNORE Distar, LLC | LRK |
| Oct 16, 2014 | K133390 | NDX DORSAL APPLIANCE Institute For Quality Resource Management | LRK |
| Sep 11, 2014 | K140429 | CRANE ACRYLIC HERBST APPLIANCE Crane Dental Laboratory, Inc. | LRK |
| Jul 25, 2014 | K140777 | ZQUIET-SA Sleeping Well, LLC | LRK |
| Jul 24, 2014 | K133683 | MICR02 OSA DEVICE Microdental, Inc. | LRK |
| Jun 26, 2014 | K140435 | MEDLEY GOLD American Dental Sleep Medicine, Ip, LLC | LRK |
| Jun 20, 2014 | K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX Somnomed, Inc. | LRK |
| May 29, 2014 | K132506 | SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY Michael D Williams Dds PA | LRK |
| May 8, 2014 | K130067 | MRNA APPLIANCE Biomodeling Solutions, Lls | LRK |
| Apr 25, 2014 | K132933 | THE MOSES ELITE APPLIANCE Allen J. Moses, Dds, Ltd. | LRK |
| Dec 18, 2013 | K130797 | LUCO HYBRID OSA APPLIANCE Luco Hybrid Osa Appliance, Inc., CA | LRK |
| Oct 18, 2013 | K130504 | ASA ORAL APPLIANCES American Sleep Association | LRK |
| Sep 9, 2013 | K131138 | RESPIRE PINK SERIES - HERBST Respire Medical | LRK |
| Jul 17, 2013 | K113126 | ACRYLIC HERBST APPLIANCE Gergens Orthodontic Lab | LRK |
| May 17, 2013 | K130558 | SOMNODENT HERBST; CLASSIC, FLEX Somnomed, Inc. | LRK |
| Apr 5, 2013 | K123410 | HEALTHY SLEEP APPLIANCE Healthy Sleep Dental Laboratory | LRK |
| Mar 8, 2013 | K121285 | ORAVAN OSA New Jersey Snoring Solutions | LRK |
| Jan 10, 2013 | K122391 | MEDTRONIC XOMED, INC. Medtronic Xomed, Inc. | LRK |
| Jan 4, 2013 | K113516 | THERASOM-CAST Family Dental Services, P.C. | LRK |
| Dec 7, 2012 | K122475 | ZQUIET PRO-PLUS Sleeping Well, LLC | LRK |
| Oct 17, 2012 | K121344 | NU SLEEP Rh Associates, LLC | LRK |
| Sep 28, 2012 | K121761 | SOMNOGUARD SP SOFT Tomed Dr. Toussaint GmbH | LRK |
| Jun 27, 2012 | K120372 | DR GREENBURGS HYBRID VACUUM Always More Marketing, Inc. | LRK |
| Jun 27, 2012 | K120371 | DR GREENBURGS HYBRID ACRYLIC Always More Marketing, Inc. | LRK |
| Jun 11, 2012 | K113022 | PURESLEEP Sleep Science Partners, Inc. | LRK |
| May 30, 2012 | K121340 | SOMNODENT G2 Somnomed, Inc. | LRK |
| Mar 23, 2012 | K103704 | REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP Zephyr Sleep Technologies, Inc., CA | LRK |
| Mar 1, 2012 | K113569 | APNEARX Apnea Science Corporation | LRK |
| Feb 10, 2012 | K110623 | PILLAR PALATAL IMPLANT SYSTEM Medtronic Xomed, Inc. | LRK |
| Dec 23, 2011 | K111680 | DR. GREENSBURG'S HYBRID Always More Marketing, Inc. | LRK |
| Nov 16, 2011 | K112205 | SNORERX 9.0 Consumer Health Products, Inc. | LRK |
| Aug 23, 2011 | K111207 | RESPIRE BLUE SERIES Respire Medical | LRK |
| Jul 22, 2011 | K111110 | APNEA GUARD Advanced Brain Monitoring, Inc. | LRK |
| Jul 22, 2011 | K111009 | ACRYLIC HERBST APPLIANCE Embassy Dental Laboratory | LRK |
| May 25, 2011 | K102463 | GOOD NIGHT Larry V Connell, Dmd | LRK |
| May 12, 2011 | K101155 | AURADORM (NEUROMUSCULAR SLEEP) Sleepwright | LRK |
| Mar 28, 2011 | K102521 | PANTINO PRO POSITINER Somnomed, Inc. | LRK |
| Feb 25, 2011 | K103004 | SNORE GUARD Ranir, LLC | LRK |
| Feb 23, 2011 | K103076 | DYNAFLEX Dyna Flex | LRK |
| Nov 19, 2010 | K100185 | SLEEP APP Sleep Medicine Network, Inc. | LRK |
| Sep 8, 2010 | K102118 | SNORE GUARD ADVANCE Ranir, LLC | LRK |
| Aug 18, 2010 | K101709 | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) Steven B. Lamberg, Dds | LRK |
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