510(k) Report

Devices descending from K972424

18 later devices reach Silentnite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130504Asa Oral AppliancesAmerican Sleep Association20132—
+1K121761Somnoguard SP SoftTomed Dr. Toussaint GmbH20122—
+1K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc.20120—
+1K120371DR Greenburgs Hybrid AcrylicAlways More Marketing, Inc.20120—
+1K111680DR. Greensburg's HybridAlways More Marketing, Inc.20116—
+1K013808SleepbiteDental Imagineers, LLC200211—
+2K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co.20261—
+2K253868QuietLab ProQuietLab, LLC20250—
+2K182312Zyppah Anti-Snoring DeviceAlways More Marketing20193—
+2K163580ASD Oral AppliancesAmerican Sleep Dentistry20171—
+2K150566OnirisSas Oniris20160—
+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—
+3K203462Advanced Dental ApplianceDasoft Partners20210—
+3K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+3K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097—