510(k) Report

Devices descending from K082207

44 later devices reach Orthocad IQ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1520863Shape Ortho System3Shape A/S201633—
+1K150702Exceed TxGreat Lakes Orthodontics, Ltd.20160—
+1K123118Insignia DigicastOrmco Corp.20135—
+1K121524InsigniaOrmco Corp.20123—
+2K232549NemoCastSoftware Nemotec S.L.20230—
+2K232429Titan Dental DesignClearadvance, LLC20231—
+2K212173HDH Treatment Planning SystemCdb Corporation20220—
+2K203442Inbrace Orthodontic SystemSwift Health Systems, Inc.20211—
+2K192701DIBS (Digital Indirect Bonding System)Orthoselect, LLC20200—
+2K181271Signature Orthodontic SystemSignature Orthodontics20184—
+2K171634Ortho System3Shape A/S201814—
+2K171122CEREC Ortho SoftwareDentsply Sirona20185—
+2K171295ULab Systems Treatment Planning SoftwareUlab Systems, Inc.201813—
+2K163677Ortho System3Shape A/S20170—
+2K123416Insignia with IteroOrmco Corp.20130—
+3K253343Celebrace SoftwareCelebrace20250—
+3K233625Raydent SWRay Co., Ltd.20242—
+3K232564Align StudioLaon Medi, Inc.20241—
+3K223518iOrthoShanghai EA Medical Instruments Co., Ltd.20232—
+3K222764LightForce Orthodontic SystemLightforce Orthodontics20221—
+3K212770VisionSoftsmile, Inc.20212—
+3K201036PlaniMax Orthodontic SoftwareChoice Biotech, Inc.20200—
+3K192847AutolignDiorco Co., Ltd.20200—
+3K200772ULab Systems uDesign SoftwareUlab Systems, Inc.20200—
+3K191720BRUIS Software SuiteMechanodontics, Inc.20203—
+3K193390CS Model+Trophy20200—
+3K183542Signature Orthodontic SystemSignature Orthodontics20191—
+3K181112Orchestrate 3DOrchestrate 3D201831
+3K180941Ortho System3Shape A/S20188—
+4K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.20260—
+4K252507SmileInspectorAmv Consulting, LLC20260—
+4K250198Laon OrthoLaon Medi, Inc.20250—
+4K241153Progressive Orthodontics AppProgressive Aligners, Inc.20240—
+4K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+4K233616Clevaligner Software (V1.0.0)Clevaligner, Ltd.20240—
+4K232827LightForce Orthodontic SystemLightforce Orthodontics20230—
+4K213916ArchForm Orthodontic Software SystemArchform, Inc.20211—
+4K212828BRIUS Planner SoftwareBrius Technologies, Inc.20212—
+4K201940Braces on Demand BracketBraces on Demand, Inc.20200—
+4K192244Arcad SmileStudio and Aligner SystemArcadlab20201—
+4K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics20200—
+5K253565SureSmile SoftwareDentsply Sirona, Inc.20260—
+5K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+5K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GBlue Sky Bio, LLC20230—