Dental design & orthodontic software: manufacturers and brands
50 companies make or specify dental software products among the 57 that list one with FDA, under 1,029 brand and model names. FDA has issued 45 510(k) clearances in this category, 21 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental software product manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | MedentiBase Titaniumbase abutment · Multi-unit TitaniumBase & Multi-unit Titanium Cap · Neodent Titanium Block for Medentika Holder · Pre-milled Abutment Blank for CARES® · +8 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | SureSmile Advanced Software · SureSmile Aligner Software · SureSmile Orthodontic Software | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A1 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A2 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3 · BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A3.5 · +111 | 56 | 2026 |
| Terrats Medical, S.L. | Spain | Maker | Terrats Medical S.L. | 23 | 2026 |
| Align Technology, Inc. | United States | Maker | iGo · iGo Plus · Invisalign ART · Invisalign Assist · +23 | 16 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | AbutmentCAD · Clinical Screw Multi-unit Abutment N1 Trioval Conical Connection · Clinical Screw N1 Base · Clinical Screw N1 Trioval Conical Connection · +32 | 94 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | RAYDENT SW | 21 | 2026 |
| Elos Medtech Pinol A/S | Denmark | Maker | Elos Accurate Customized Abutment · Elos Accurate Hybrid Base · Elos Accurate Hybrid Base and Customized Abutment with Prosthetic Screws · Elos Accurate Hybrid Base Engaging · +5 | 14 | 2026 |
| Sybron Dental Specialties | United States | Maker | Spark Clear Aligner System | 203 | 2026 |
| Southern Implants, Inc. | South Africa | Maker | Angulated Screw Channel Solution Abutments & SI-BASE Abutments · PROVATA Implant System · Single Platform SP1 Implant System and accessories · TIB Abutment System · +1 | 22 | 2024 |
| Implant Protesis Dental 2004, S.L. | Spain | Maker | Angled Multi-unit Screw M1.4 · Angled Multi-unit Screw M1.6 · Angled Multi-unit Screw M1.8 · Angled Multi-unit Screw M2 · +751 | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | IPS e.max CAD Abutment Solutions- extra systems · Telio CAD Abutment Solutions- extra systems | 94 | 2026 |
| BioHorizons Implant Systems, Inc. | United States | Maker | CEREC Compatible Ti-Bases · Conical Ti Base Abutments | 41 | 2026 |
| Implant Direct | United States | Maker | InterActive SMARTBase Abutments · Legacy SMARTbase Abutments · SMARTbase Abutment System | 24 | 2023 |
| Young Innovations Inc | United States | Maker | Preat Abutments | 23 | 2025 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Plan Ortho Module | 20 | 2024 |
| Park Dental Research Corp | United States | Maker | Orchestrate 3D | 8 | 2026 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | NP CloseFit Ti Pre Milled MDTK Abutment Blank · RP CloseFit Ti Pre Milled MDTK Abutment Blank · RS CloseFit Ti Pre Milled MDTK Abutment Blank · Ti Base RS Abutment · +3 | 3 | 2026 |
| LightForce Orthodontics, Inc | United States | Maker | LightForce Orthodontic System | 3 | 2023 |
| Dental Imaging Technologies Corporation | United States | Maker | CS Model+ | 2 | 2026 |
| LAON MEDI Inc. | South Korea | Maker | Laon Ortho | 2 | 2025 |
| Cdb Corporation | United States | Maker | HDH Treatment Planning System | 9 | 2022 |
| uLab Systems, Inc. | United States | Maker | ULab Systems UDesign · uLab Systesm uDesign IDB | 4 | 2022 |
| Software Nemotec, S.L. | Spain | Maker | NemoCast | 2 | 2023 |
| Hangzhou ChohoTech Co., Ltd | China | Maker | LingOral Dental Design System | 1 | 2026 |
| Celebrace | United States | Maker | Celebrace Software | 1 | 2025 |
| Creodent Hudson Valley | United States | Maker | Solidex | 1 | 2026 |
| Archform Inc. | United States | Maker | ArchForm Orthodontic Software System | 1 | 2021 |
| Progressive Aligners Inc | United States | Maker | Medit Orthodontic Suite · Progressive Orthodontics App | 1 | 2024 |
| ClearAdvance, LLC | United States | Maker | Titan Dental Design | 1 | 2023 |
| Rgorithm Korea | South Korea | Maker | TRUST | 1 | 2023 |
| SoftSmile, Inc. | United States | Maker | Vision | 1 | 2021 |
| Shanghai EA Medical Instruments Co., Ltd. | China | Maker | — | 1 | 2023 |
| 3Shape A/S | Denmark | Maker | Ortho System · 3Shape Ortho System · 3Shape Splint Design · Abutment Design · +1 | 7 | 2020 |
| Brius | United States | Maker | Brius Software | 2 | 2021 |
| exocad GmbH | Germany | Maker | AbutmentCAD · Ceramill Mind M-Plant · Implant Module · PlanCAD Premium AbutmentCAD | 1 | 2021 |
| Inteware Co., Ltd | Taiwan | Maker | OrthoAnalysis Software | 1 | 2019 |
| OrthoSelect | United States | Maker | DIBS AI | 1 | 2020 |
| GuideMia Technologies, LLC | United States | Maker | GuideMia OrthoPlus Software | 1 | 2017 |
| Micro Precision Swiss, LLC | United States | Maker | Abutment Screw Retrieval Instrument · Implant Retrieval Instrument | — | — |
| Medit Corp. | South Korea | Maker | Medit Orthodontic Suite · Progressive Orthodontics App. | — | — |
| New Image Dental Laboratory, Inc. | United States | Maker | Abutment, implant, dental, endosseous, Straumann CARES M-Series CAD/CAM System | — | — |
| Implant Logistics / AMS Micromedical | United States | Maker | Implant Logistics, Inc; Implant-One | — | — |
| Proto3000 Inc. | Canada | Maker | Exocad Exoplan | — | — |
| Preferred Oral Design Limitada | Costa Rica | Maker | Straumann CARES M-Series CAD/CAM System | — | — |
| EXCELDENT Dental Technology Development Co., Ltd. | China | Maker | Dess Implant | — | — |
| Progressive America Inc | United States | Maker | Medit Orthodontic Suite | — | — |
| Lorelli Technologies LLC | United States | Maker | InSmile Braces Orthodontic System | — | — |
| Shimmer Computerized Dental Technology Co.,LTD | China | Maker | Dess Implant | — | — |
| Image Instruments GmbH | Germany | Maker | OnyxCeph | — | — |
| PaloDEx Group Oy | Finland | Foreign exporter | DTX Studio Lab | 9 | 2024 |
| National Dentex LLC | United States | Contract manufacturer | DESS Ti Base Abutments | 1 | 2012 |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | Zirconia Implant System | — | — |
| Ray America Inc. | United States | Lister | RAYDENT SW | — | — |
| Acer Dental Lab Co Ltd | Hong Kong SAR China | Foreign exporter | Dess Implant | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental software products are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Orthodontic SoftwarePNN | 2 | 872.5470 | 28 | 37 |
| Dental Abutment Design Software for Dental LaboratoryPNP | 2 | 872.3630 | 24 | 8 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Oct 2026 | K260421 | LuxDesign | LuxCreo Inc. | PNN Orthodontic Software |
| 7 Oct 2026 | K262378 | Dr.AlignNavi | InnoDtech, Inc. | PNN Orthodontic Software |
| 25 Sep 2026 | K262196 | Invisalign System | Align Technology, Inc. | PNN Orthodontic Software |
| 8 May 2026 | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd | PNN Orthodontic Software |
| 4 Mar 2026 | K253565 | SureSmile Software | Dentsply Sirona, Inc. | PNN Orthodontic Software |
| 7 Jan 2026 | K252507 | SmileInspector | Amv Consulting, LLC | PNN Orthodontic Software |
| 29 Dec 2025 | K253343 | Celebrace Software | Celebrace | PNN Orthodontic Software |
| 23 Apr 2025 | K250198 | Laon Ortho | LAON MEDI Inc. | PNN Orthodontic Software |
| 26 Dec 2024 | K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | PNP Dental Abutment Design Software for Dental Laboratory |
| 11 Oct 2024 | K241153 | Progressive Orthodontics App | Progressive Aligners Inc | PNN Orthodontic Software |
| 16 May 2024 | K233625 | RAYDENT SW | Ray Co., Ltd, | PNN Orthodontic Software |
| 14 Mar 2024 | K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | PNP Dental Abutment Design Software for Dental Laboratory |
| 12 Mar 2024 | K232564 | Align Studio | LAON MEDI Inc. | PNN Orthodontic Software |
| 11 Jan 2024 | K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | PNN Orthodontic Software |
| 21 Nov 2023 | K232549 | NemoCast | Software Nemotec, S.L. | PNN Orthodontic Software |
| 13 Oct 2023 | K232429 | Titan Dental Design | ClearAdvance, LLC | PNN Orthodontic Software |
| 18 Jul 2023 | K221107 | TRUST | Rgorithm Korea | PNP Dental Abutment Design Software for Dental Laboratory |
| 13 Jun 2023 | K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | PNN Orthodontic Software |
| 25 Jan 2022 | K212173 | HDH Treatment Planning System | Cdb Corporation | PNN Orthodontic Software |
| 21 Dec 2021 | K212770 | Vision | SoftSmile, Inc. | PNN Orthodontic Software |
| 16 Dec 2021 | K213916 | ArchForm Orthodontic Software System | Archform Inc. | PNN Orthodontic Software |
| 1 Oct 2021 | K212828 | BRIUS Planner Software | Brius | PNN Orthodontic Software |
| 21 Jul 2021 | K193352 | AbutmentCAD | exocad GmbH | PNP Dental Abutment Design Software for Dental Laboratory |
| 19 Feb 2021 | K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | PNN Orthodontic Software |
| 22 Dec 2020 | K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | PNN Orthodontic Software |
| 7 Oct 2020 | K200100 | Abutment Design | 3Shape A/S | PNP Dental Abutment Design Software for Dental Laboratory |
| 19 Aug 2020 | K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona, Inc. | PNP Dental Abutment Design Software for Dental Laboratory |
| 21 Jul 2020 | K192847 | AUTOLIGN | Diorco Co., Ltd. | PNN Orthodontic Software |
| 23 Jun 2020 | K200772 | ULab Systems uDesign Software | uLab Systems, Inc. | PNN Orthodontic Software |
| 5 Jun 2020 | K193003 | NemoCast | Software Nemotec, S.L. | PNN Orthodontic Software |
| 21 Apr 2020 | K192701 | DIBS (Digital Indirect Bonding System) | OrthoSelect | PNN Orthodontic Software |
| 17 Apr 2020 | K191720 | BRUIS Software Suite | Mechanodontics, Inc. | PNN Orthodontic Software |
| 2 Apr 2020 | K193390 | CS Model+ | Carestream Dental LLC | PNN Orthodontic Software |
| 27 Nov 2019 | K191911 | 3Shape Splint Design | 3Shape A/S | PNN Orthodontic Software |
| 12 Sep 2019 | K183695 | OrthoAnalysis Software | Inteware Co., Ltd | PNN Orthodontic Software |
| 1 Mar 2019 | K181932 | DTX Studio design | Nobel Biocare Services AG | PNP Dental Abutment Design Software for Dental Laboratory |
| 26 Nov 2018 | K181112 | Orchestrate 3D | Orchestrate 3D | PNN Orthodontic Software |
| 17 Oct 2018 | K180941 | Ortho System | 3Shape A/S | PNN Orthodontic Software |
| 17 Jan 2018 | K171634 | Ortho System | 3Shape A/S | PNN Orthodontic Software |
| 11 Jan 2018 | K171122 | CEREC Ortho Software | Dentsply Sirona, Inc. | PNN Orthodontic Software |