510(k) Report

Devices descending from K170692

2 later devices reach Respire Pink Series with DentiTrac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223624Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental20230—
+1K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—