510(k) Report

Devices descending from K190107

10 later devices reach VeriSplint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries)202161
+1K201173E-GuardEnvisiontec GmbH202021
+2K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.20260—
+2K231775GR Resin System MSIPro3Dure Medical20240—
+2K232448FREEPRINT® splintmasterDetax GmbH20230—
+2K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+2K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc.20221—
+2K211415GR Splint Resin SystemPro3Dure Medical GmbH20212—
+2K210940LuxaPrint Ortho PlusDmg Digital Enterprises SE20210—
+3K232087Dental LT Comfort ResinFormlabs Ohio, Inc.20240—