Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Orthodontic Software

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.

FDA codePNNClass221 CFR872.5470Pathway510(k)CategoryDental design & orthodontic software
Companies listing it
2928 makers
Brands and models
61
510(k) clearances
3718 in five years
FDA name
Orthodontic Software
2016: 12017: 22018: 52019: 22020: 72021: 42022: 12023: 32024: 42025: 22026: 619801990200020102020

510(k) clearances per year, 1976–2026

Companies that list PNN

29 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerSureSmile Advanced Software · SureSmile Aligner Software · SureSmile Orthodontic Software1482026
Align Technology, Inc.United StatesMakeriGo · iGo Plus · Invisalign ART · Invisalign Assist · +23162026
Ray Co., Ltd,South KoreaMakerRAYDENT SW212026
Sybron Dental SpecialtiesUnited StatesMakerSpark Clear Aligner System2032026
Blue Sky Bio, LLCUnited StatesMakerBlue Sky Plan Ortho Module202024
Park Dental Research CorpUnited StatesMakerOrchestrate 3D82026
LightForce Orthodontics, IncUnited StatesMakerLightForce Orthodontic System32023
Dental Imaging Technologies CorporationUnited StatesMakerCS Model+22026
LAON MEDI Inc.South KoreaMakerLaon Ortho22025
Cdb CorporationUnited StatesMakerHDH Treatment Planning System92022
uLab Systems, Inc.United StatesMakerULab Systems UDesign · uLab Systesm uDesign IDB42022
Software Nemotec, S.L.SpainMakerNemoCast22023
Hangzhou ChohoTech Co., LtdChinaMakerLingOral Dental Design System12026
CelebraceUnited StatesMakerCelebrace Software12025
Archform Inc.United StatesMakerArchForm Orthodontic Software System12021
Progressive Aligners IncUnited StatesMakerMedit Orthodontic Suite · Progressive Orthodontics App12024
ClearAdvance, LLCUnited StatesMakerTitan Dental Design12023
SoftSmile, Inc.United StatesMakerVision12021
Shanghai EA Medical Instruments Co., Ltd.ChinaMaker—12023
3Shape A/SDenmarkMakerOrtho System · 3Shape Ortho System · 3Shape Splint Design72020
BriusUnited StatesMakerBrius Software22021
Inteware Co., LtdTaiwanMakerOrthoAnalysis Software12019
OrthoSelectUnited StatesMakerDIBS AI12020
GuideMia Technologies, LLCUnited StatesMakerGuideMia OrthoPlus Software12017
Medit Corp.South KoreaMakerMedit Orthodontic Suite · Progressive Orthodontics App.——
Progressive America IncUnited StatesMakerMedit Orthodontic Suite——
Lorelli Technologies LLCUnited StatesMakerInSmile Braces Orthodontic System——
Image Instruments GmbHGermanyMakerOnyxCeph——
Ray America Inc.United StatesListerRAYDENT SW——

510(k) clearances

Decided510(k)DeviceApplicant
23 Oct 2026K260421LuxDesignLuxCreo Inc.
7 Oct 2026K262378Dr.AlignNaviInnoDtech, Inc.
25 Sep 2026K262196Invisalign SystemAlign Technology, Inc.
8 May 2026K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd
4 Mar 2026K253565SureSmile SoftwareDentsply Sirona, Inc.
7 Jan 2026K252507SmileInspectorAmv Consulting, LLC
29 Dec 2025K253343Celebrace SoftwareCelebrace
23 Apr 2025K250198Laon OrthoLAON MEDI Inc.
11 Oct 2024K241153Progressive Orthodontics AppProgressive Aligners Inc
16 May 2024K233625RAYDENT SWRay Co., Ltd,
12 Mar 2024K232564Align StudioLAON MEDI Inc.
11 Jan 2024K233616Clevaligner Software (V1.0.0)Clevaligner, Ltd.
21 Nov 2023K232549NemoCastSoftware Nemotec, S.L.
13 Oct 2023K232429Titan Dental DesignClearAdvance, LLC
13 Jun 2023K223518iOrthoShanghai EA Medical Instruments Co., Ltd.
25 Jan 2022K212173HDH Treatment Planning SystemCdb Corporation
21 Dec 2021K212770VisionSoftSmile, Inc.
16 Dec 2021K213916ArchForm Orthodontic Software SystemArchform Inc.
1 Oct 2021K212828BRIUS Planner SoftwareBrius
19 Feb 2021K203442Inbrace Orthodontic SystemSwift Health Systems, Inc.
22 Dec 2020K201036PlaniMax Orthodontic SoftwareChoice Biotech, Inc.
21 Jul 2020K192847AUTOLIGNDiorco Co., Ltd.
23 Jun 2020K200772ULab Systems uDesign SoftwareuLab Systems, Inc.
5 Jun 2020K193003NemoCastSoftware Nemotec, S.L.
21 Apr 2020K192701DIBS (Digital Indirect Bonding System)OrthoSelect
17 Apr 2020K191720BRUIS Software SuiteMechanodontics, Inc.
2 Apr 2020K193390CS Model+Carestream Dental LLC
27 Nov 2019K1919113Shape Splint Design3Shape A/S
12 Sep 2019K183695OrthoAnalysis SoftwareInteware Co., Ltd
26 Nov 2018K181112Orchestrate 3DOrchestrate 3D
17 Oct 2018K180941Ortho System3Shape A/S
17 Jan 2018K171634Ortho System3Shape A/S
11 Jan 2018K171122CEREC Ortho SoftwareDentsply Sirona, Inc.
9 Jan 2018K171295ULab Systems Treatment Planning SoftwareuLab Systems, Inc.
20 Apr 2017K163677Ortho System3Shape A/S
24 Mar 2017K162850GuideMia Ortho+GuideMia Technologies, LLC
28 Apr 2016K1520863Shape Ortho System3Shape A/S

Official records: FDA product classification for PNN · 21 CFR 872.5470.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026