510(k) Report

Devices descending from K171634

14 later devices reach Ortho System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223518iOrthoShanghai EA Medical Instruments Co., Ltd.20232—
+1K201036PlaniMax Orthodontic SoftwareChoice Biotech, Inc.20200—
+1K192847AutolignDiorco Co., Ltd.20200—
+1K191720BRUIS Software SuiteMechanodontics, Inc.20203—
+1K193390CS Model+Trophy20200—
+1K181112Orchestrate 3DOrchestrate 3D201831
+2K241153Progressive Orthodontics AppProgressive Aligners, Inc.20240—
+2K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXBlue Sky Bio, LLC20241—
+2K213916ArchForm Orthodontic Software SystemArchform, Inc.20211—
+2K212828BRIUS Planner SoftwareBrius Technologies, Inc.20212—
+3K253565SureSmile SoftwareDentsply Sirona, Inc.20260—
+3K242892Cristaline Aligners Z FLXCristaline Aligners GmbH20240—
+3K232429Titan Dental DesignClearadvance, LLC20231—
+4K253343Celebrace SoftwareCelebrace20250—