510(k) Report

Devices descending from K191427

3 later devices reach Halley resin system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231578Lucitone Digital Print Denture SystemDentsply Sirona20232—
+2K262300Denture Base Resin V2Formlabs Ohio, Inc.20260—
+2K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.20240—