510(k) Report

Devices descending from K955822

12 later devices reach Removable Herbst Appliance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023836The Suad DeviceStrong Dental, Inc.200311—
+2K140435Medley GoldAmerican Dental Sleep Medicine, Ip, LLC20140—
+2K131138Respire Pink Series - HerbstRespire Medical20137—
+2K060795SomnofitStrategic Counsel Sarl20060—
+2K060744O'brien Mpa (Mandibular Positioning Applicance)O'Brien Dental Lab, Inc.20060—
+3K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+3K170692Respire Pink Series with DentiTracRespire Medical Holding20172—
+3K150572Respire Pink Series-Herbst-EFRespire Medical Holding201553
+3K140429Crane Acrylic Herbst ApplianceCrane Dental Laboratory, Inc.20140—
+4K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—
+4K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical Holdings20201—
+5K214096Respire ClearRespire Medical, LLC20220—