510(k) Report

Devices descending from K150432

23 later devices reach Idodentine Disc, Idodentine Block through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201683PMMA BlockHuge Dental Material Co., Ltd.20202—
+1K200676ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPAZirkonzahn Srl20200—
+1K190107VeriSplintWhip Mix Corporation201910—
+1K180578Harvest Dental Polymer BlocksHarvest Dental Products, LLC20183—
+1K180562Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon…Zirkonzahn GmbH20181—
+1K153490DD medical polymersDental Direkt GmbH20161—
+2K230410DD medical polymers (PMMA)Dental Direkt GmbH20230—
+2K223706Pmma BlockHuliang (Shanghai) Bio-Tech Co., Ltd.20231—
+2K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries)202161
+2K201173E-GuardEnvisiontec GmbH202021
+2K192153Portux CAD/CAM DiscNew Stetic, SA20192—
+2K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2DMG Chemisch-Pharmazeutische Fabrik GmbH20190—
+3K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.20260—
+3K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.20260—
+3K231775GR Resin System MSIPro3Dure Medical20240—
+3K232448FREEPRINT® splintmasterDetax GmbH20230—
+3K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+3K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc.20221—
+3K212017Thermeo SystemPro3Dure Medical GmbH20221—
+3K211415GR Splint Resin SystemPro3Dure Medical GmbH20212—
+3K210940LuxaPrint Ortho PlusDmg Digital Enterprises SE20210—
+4K260031Thermeo® I MsiPro3Dure Medical GmbH20260—
+4K232087Dental LT Comfort ResinFormlabs Ohio, Inc.20240—