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 16, 2021 | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge Prismatik Dentalcraft, Inc. | LRK |
| Mar 10, 2021 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) Meris Investment Group | LRK |
| Feb 25, 2021 | K203477 | Classic Orthoapnea S.L., ES | LRK |
| Feb 19, 2021 | K203462 | Advanced Dental Appliance Dasoft Partners | LRK |
| Feb 12, 2021 | K202651 | NOA Sleep Apnea and Snoring Device Orthoapnea S.L., ES | LRK |
| Jan 14, 2021 | K201719 | Vital Sleep The Snore Reliever Company, LLC | LRK |
| Nov 23, 2020 | K201484 | Somnos Anti-Snoring Mouth Guard Koncept Innovators, LLC | LRK |
| Nov 20, 2020 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring Prosomnus Sleep Technologies, Inc. | LRK |
| Sep 3, 2020 | K202499 | Diamond Digital Sleep Orthotic (DDSO) Diamond Orthotic Laboratory | LRK |
| Feb 5, 2020 | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) Respire Medical Holdings | LRK |
| Jan 3, 2020 | K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution) Mpowrx Health and Wellness Products 2012, Inc., CA | LRK |
| Dec 11, 2019 | K191618 | SleepTight Mouthpiece STZ Michael D Williams Dds PA | LRK |
| Sep 17, 2019 | K181416 | Sapphire Dorsal Comfort Fit Crane Dental Laboratory, Inc. | LRK |
| Aug 29, 2019 | K190236 | O2Vent Optima Oventus Manufacturing Pty, Ltd., AU | LRK |
| Jul 17, 2019 | K183270 | Silent Nite sl Prismatik Dentalcraft, Inc. | LRK |
| Jul 2, 2019 | K190687 | Twilite Appliance Stephen J Harkins, Dds, PC | LRK |
| Jun 7, 2019 | K190051 | TD Clip Zephyr Sleep Technologies, Inc., CA | LRK |
| May 8, 2019 | K183443 | SomnoDent Avant Somnomed, Inc. | LRK |
| Apr 11, 2019 | K190058 | PureSleep (OTC use) Sleep Science Partners, Inc. | LRK |
| Mar 8, 2019 | K173064 | ZAPnea Oral Appliance B. Fareid, Dds, PC | LRK |
| Feb 13, 2019 | K182661 | Kava and Kava with Herbst Sketchpad Innovations, LLC | LRK |
| Feb 11, 2019 | K180691 | TrueDorsal Devices True Function Laboratory, Inc. | LRK |
| Jan 24, 2019 | K182312 | Zyppah Anti-Snoring Device Always More Marketing | LRK |
| Jan 11, 2019 | K182202 | SLEEPAPP Comfort Acrylics, Inc. | LRK |
| Dec 6, 2018 | K181107 | Elevo® Kit Snoring Intervention Device Zelegent, Inc. | LRK |
| Nov 21, 2018 | K181123 | ApnoDent Appliance Apnomed, Inc. | LRK |
| Nov 16, 2018 | K181396 | Oral Device OA, Oral Device S Passion For Life Healthcare (Uk) Limited, GB | LRK |
| Aug 31, 2018 | K181482 | myTAP2 Airway Management, Inc. | LRK |
| Jul 10, 2018 | K172991 | Advanced Dental Applicance Dasoft Partners | LRK |
| Jun 26, 2018 | K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance Moses Appliances, LLC | LRK |
| Jun 12, 2018 | K180124 | ZQuiet Sleeping Well, LLC | LRK |
| Mar 26, 2018 | K172760 | REST EAZY Appliance Insert Molding Solutions, Inc. | LRK |
| Feb 22, 2018 | K171576 | The Panthera Anti-Snoring X3 Device Panthera Dental, Inc., CA | LRK |
| Jan 2, 2018 | K171529 | Snorer's Friend Scope Healthcare Technologies Pty, Ltd., AU | LRK |
| Nov 28, 2017 | K170053 | Meridian PM The Center For Craniofacial & Dental Sleep Medicine | LRK |
| Nov 24, 2017 | K170578 | True Function Adjustable Herbst Appliances True Function Laboratory, Inc. | LRK |
| Aug 18, 2017 | K170825 | SnoreRx Apnea Sciences Corporation | LRK |
| Jul 11, 2017 | K171316 | O2Vent W Oventus Manufacturing Pty, Ltd., AU | LRK |
| Jun 8, 2017 | K163580 | ASD Oral Appliances American Sleep Dentistry | LRK |
| May 26, 2017 | K170692 | Respire Pink Series with DentiTrac Respire Medical Holding | LRK |
| Feb 7, 2017 | K161980 | Fuselier Intraoral Nighttime Device (FIND) Fuselier Enterprises, LLC | LRK |
| Dec 15, 2016 | K162192 | BluePro Bluesom, FR | LRK |
| Nov 9, 2016 | K152660 | HYPNOSPAD Somnics, Inc., TW | LRK |
| Sep 23, 2016 | K161832 | O2VENT T Oventus Manufacturing Pty, Ltd., AU | LRK |
| Sep 20, 2016 | K162306 | SomnoDent ALPHA Somnomed, Inc. | LRK |
| Sep 1, 2016 | K160531 | Noiselezz Firma Ingemarsson, DK | LRK |
| Aug 9, 2016 | K153200 | SnoreRx Apnea Sciences Corporation | LRK |
| Jul 12, 2016 | K160123 | Apinator Allen J. Moses, Dds, Ltd. | LRK |
| Mar 31, 2016 | K153291 | SICAT OPTISLEEP Sicat GmbH & Co. KG, DE | LRK |
| Mar 21, 2016 | K150566 | Oniris Sas Oniris, FR | LRK |
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