510(k) Report

Devices descending from K971794

35 later devices reach Elastic Mandibular Advancement (Ema) Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232735EMA 3DEma Sleep Incorporated20241—
+1K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+1K113516Therasom-CastFamily Dental Services, P.C.20132—
+1K121344NU SleepRh Associates, LLC20120—
+1K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+1K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+1K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+1K113201Narval CCResmed Sas201115—
+1K013808SleepbiteDental Imagineers, LLC200211—
+1K973884Elastic Mandibular Advancement - Titration (Ema-T) AppilanceFrantz Design, Inc.19981—
+2K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+2K252698NightGuard Aire MaxNightguard Express, LLC20250—
+2K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+2K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+2K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+2K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+2K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+2K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+2K060795SomnofitStrategic Counsel Sarl20060—
+2K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds20068—
+2K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds20059—
+3K261912SnØreNegatØrDnB Innovations, LLC20260—
+3K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+3K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+3K203462Advanced Dental ApplianceDasoft Partners20210—
+3K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+3K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+3K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+3K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+3K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—
+4K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+4K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+4K230495Serena Sleep Night GuardMeris Investment Group20231—
+4K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+5K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—