510(k) Report

Devices descending from K902790

36 later devices reach NAPA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971794Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc.199735—
+2K232735EMA 3DEma Sleep Incorporated20241—
+2K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+2K113516Therasom-CastFamily Dental Services, P.C.20132—
+2K121344NU SleepRh Associates, LLC20120—
+2K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+2K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+2K113201Narval CCResmed Sas201115—
+2K013808SleepbiteDental Imagineers, LLC200211—
+2K973884Elastic Mandibular Advancement - Titration (Ema-T) AppilanceFrantz Design, Inc.19981—
+3K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+3K252698NightGuard Aire MaxNightguard Express, LLC20250—
+3K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+3K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+3K153291Sicat OptisleepSicat GmbH & Co. KG20163—
+3K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—
+3K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.20149—
+3K103704Remotely Controlled Mandibular Positioner, RCMPZephyr Sleep Technologies, Inc.20120—
+3K060795SomnofitStrategic Counsel Sarl20060—
+3K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds20068—
+3K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds20059—
+4K261912SnØreNegatØrDnB Innovations, LLC20260—
+4K232025Hushd Pro AveraGood Sleep CO Pte, Ltd.20241—
+4K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+4K203462Advanced Dental ApplianceDasoft Partners20210—
+4K202651NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L.20210—
+4K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory20200—
+4K182661Kava and Kava with HerbstSketchpad Innovations, LLC20191—
+4K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc.20181—
+4K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—
+5K252976Park Dental Nylon MADPark Dental Research Corp.20250—
+5K251784Hushd Pro Z-LinkGood Sleep CO Pte, Ltd.20250—
+5K230495Serena Sleep Night GuardMeris Investment Group20231—
+5K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device…Prosomnus Sleep Technologies20220—
+6K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—