510(k) Report

Devices descending from K190043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc.20222—
+1K191427Halley resin systemDentsply Sirona20193—
+2K260569DB 4000 High Impact Denture BaseCarbon, Inc.20260—
+2K260376Denture BaseShandong Huge Dental Material Corporation20260—
+2K231578Lucitone Digital Print Denture SystemDentsply Sirona20232—
+3K262300Denture Base Resin V2Formlabs Ohio, Inc.20260—
+3K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.20240—