510(k) Report

Devices descending from K083051

5 later devices reach Flowtain & Flowtain LV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products20230—
+1K130237Pontic PaintReliance Orthodontic Products, Inc.20130—
+1K123348Clear Aligner AdhesiveReliance Orthodontic Products, Inc.20130—
+1K101951Light Cure RetainerReliance Orthodontic Products, Inc.20100—
+1K100301Opal Bond FlowUltradent Products, Inc.20100—