Orthodontic Software

FDA product code PNN · Class II (moderate risk) · 21 CFR 872.5470 · Dental

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

34510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K260419LingOral Dental Design SystemPNN · Traditional Hangzhou ChohoTech Co., Ltd.05/08/2026SE
K253565SureSmile SoftwarePNN · Traditional Dentsply Sirona, Inc.03/04/2026SE
K252507SmileInspectorPNN · Traditional Amv Consulting, LLC01/07/2026SE
K253343Celebrace SoftwarePNN · Traditional Celebrace12/29/2025SE
K250198Laon OrthoPNN · Traditional Laon Medi, Inc.04/23/2025SE
K241153Progressive Orthodontics AppPNN · Traditional Progressive Aligners, Inc.10/11/2024SE
K233625Raydent SWPNN · Traditional Ray Co., Ltd.05/16/2024SE
K232564Align StudioPNN · Traditional Laon Medi, Inc.03/12/2024SE
K233616Clevaligner Software (V1.0.0)PNN · Traditional Clevaligner, Ltd.01/11/2024SE
K232549NemoCastPNN · Traditional Software Nemotec S.L.11/21/2023SE
K232429Titan Dental DesignPNN · Traditional Clearadvance, LLC10/13/2023SE
K223518iOrthoPNN · Traditional Shanghai EA Medical Instruments Co., Ltd.06/13/2023SE
K212173HDH Treatment Planning SystemPNN · Traditional Cdb Corporation01/25/2022SE
K212770VisionPNN · Traditional Softsmile, Inc.12/21/2021SE
K213916ArchForm Orthodontic Software SystemPNN · Traditional Archform, Inc.12/16/2021SE
K212828BRIUS Planner SoftwarePNN · Special Brius Technologies, Inc.10/01/2021SE
K203442Inbrace Orthodontic SystemPNN · Traditional Swift Health Systems, Inc.02/19/2021SE
K201036PlaniMax Orthodontic SoftwarePNN · Traditional Choice Biotech, Inc.12/22/2020SE
K192847AutolignPNN · Traditional Diorco Co., Ltd.07/21/2020SE
K200772ULab Systems uDesign SoftwarePNN · Traditional Ulab Systems, Inc.06/23/2020SE
K193003NemoCastPNN · Traditional Software Nemotec S.L.06/05/2020SE
K192701DIBS (Digital Indirect Bonding System)PNN · Traditional Orthoselect, LLC04/21/2020SE
K191720BRUIS Software SuitePNN · Traditional Mechanodontics, Inc.04/17/2020SE
K193390CS Model+PNN · Traditional Trophy04/02/2020SE
K1919113Shape Splint DesignPNN · Traditional 3Shape A/S11/27/2019SE
K183695OrthoAnalysis SoftwarePNN · Traditional Inteware Co., Ltd.09/12/2019SE
K181112Orchestrate 3DPNN · Traditional Orchestrate 3D11/26/2018SE
K180941Ortho SystemPNN · Traditional 3Shape A/S10/17/2018SE
K171634Ortho SystemPNN · Special 3Shape A/S01/17/2018SE
K171122CEREC Ortho SoftwarePNN · Traditional Dentsply Sirona01/11/2018SE
K171295ULab Systems Treatment Planning SoftwarePNN · Traditional Ulab Systems, Inc.01/09/2018SE
K163677Ortho SystemPNN · Traditional 3Shape A/S04/20/2017SE
K162850GuideMia Ortho+PNN · Traditional Guidemia Technologies, LLC03/24/2017SE
K1520863Shape Ortho SystemPNN · Traditional 3Shape A/S04/28/2016SE

Recalls

RecallProductFirmInitiated
Z-1017-2023 Class IIInvisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign…3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may… Align Technology Inc12/05/2022Completed
Z-0334-2022 Class IIO3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions…Due to product label/labeling being altered from it's approved state. Orchestrate Orthodontic Technologies, Inc.11/11/2021Terminated