510(k) Report

Devices descending from K152086

33 later devices reach 3Shape Ortho System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232549NemoCastSoftware Nemotec S.L.20230—
+1K232429Titan Dental DesignClearadvance, LLC20231—
+1K212173HDH Treatment Planning SystemCdb Corporation20220—
+1K192701DIBS (Digital Indirect Bonding System)Orthoselect, LLC20200—
+1K171634Ortho System3Shape A/S201814—
+1K171122CEREC Ortho SoftwareDentsply Sirona20185—
+1K171295ULab Systems Treatment Planning SoftwareUlab Systems, Inc.201813—
+1K163677Ortho System3Shape A/S20170—
+2K253343Celebrace SoftwareCelebrace20250—
+2K233625Raydent SWRay Co., Ltd.20242—
+2K232564Align StudioLaon Medi, Inc.20241—
+2K223518iOrthoShanghai EA Medical Instruments Co., Ltd.20232—
+2K212770VisionSoftsmile, Inc.20212—
+2K201036PlaniMax Orthodontic SoftwareChoice Biotech, Inc.20200—
+2K192847AutolignDiorco Co., Ltd.20200—
+2K200772ULab Systems uDesign SoftwareUlab Systems, Inc.20200—
+2K191720BRUIS Software SuiteMechanodontics, Inc.20203—
+2K193390CS Model+Trophy20200—
+2K181112Orchestrate 3DOrchestrate 3D201831
+2K180941Ortho System3Shape A/S20188—
+3K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.20260—
+3K252507SmileInspectorAmv Consulting, LLC20260—
+3K250198Laon OrthoLaon Medi, Inc.20250—
+3K241153Progressive Orthodontics AppProgressive Aligners, Inc.20240—
+3K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+3K233616Clevaligner Software (V1.0.0)Clevaligner, Ltd.20240—
+3K213916ArchForm Orthodontic Software SystemArchform, Inc.20211—
+3K212828BRIUS Planner SoftwareBrius Technologies, Inc.20212—
+3K201940Braces on Demand BracketBraces on Demand, Inc.20200—
+3K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+4K253565SureSmile SoftwareDentsply Sirona, Inc.20260—
+4K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+4K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—