510(k) Report

Devices descending from K183598

14 later devices reach KeyPrint KeySplint Soft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation20250—
+1K231775GR Resin System MSIPro3Dure Medical20240—
+1K232087Dental LT Comfort ResinFormlabs Ohio, Inc.20240—
+1K232448FREEPRINT® splintmasterDetax GmbH20230—
+1K223798Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, Inc.20230—
+1K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc.20221—
+1K220894SmileGuardEnvisiontec GmbH20220—
+1K214102Glidewell Appliance Resin, Hard/SoftPrismatik Dentalcraft, Inc.20220—
+1K212448NightGuard FlexSprintray, Inc.20212—
+1K211415GR Splint Resin SystemPro3Dure Medical GmbH20212—
+1K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries)202161
+2K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.20260—
+2K221022NextDent Ortho FlexVertex-Dental B.V.20221—
+3K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—