Orthodontic Software
Dental · 21 CFR 872.5470
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Align Technology IncCompletedJan 26, 2023
Invisalign Express 10 REF 8512
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
Z-1017-2023 · View FDA record ↗ - Orchestrate Orthodontic Technologies, Inc.TerminatedUnknown
O3D ORCHESTRATE Orthodontic Technologies
Due to product label/labeling being altered from it's approved state.
Z-0334-2022 · View FDA record ↗
Registered firms
62 firms currently registered for this product code
Ulab Systems, Inc
Memphis, TN, US
Laon Medi Inc.
Gwacheon-si, Gyeonggi-do, KR
Dentsply Sirona Orthodontics Inc.
RICHARDSON, TX, US
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Align Technology Afab Poland Sp. Z O.o.
Wroclaw Dolnoslaskie, PL
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Progressive Aligners
Aliso Viejo, CA, US
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Envista (suzhou) Medical Device Co., Ltd.
Suzhou Jiangsu, CN
Lightforce Orthodontics
Wilmington, MA, US
Align Technology De Costa Rica S.r.l
Belen Heredia, CR
Inteware Co., Ltd
Chiayi County, TW
Dental Imaging Technologies Corporation
Quakertown, PA, US
Image Instruments Gmbh
Chemnitz Saxony, DE
Softsmile, Inc.
Long Island City, NY, US
Lorelli Technologies Llc
Fountain Valley, CA, US
Shanghai Ea Medical Instruments Co., Ltd.
Yangpu District Shanghai, CN
Guidemia Technologies, Llc
Buena Park, CA, US
Progressive Orthodontics Usa
Aliso Viejo, CA, US
Medit Corp.
Seoul, KR
Software Nemotec, S.l.
Leganes Madrid (Province), ES
Clearadvance, Llc
Irvine, CA, US
Great Lakes Dental Technologies, Ltd.
TONAWANDA, NY, US
Ray Co., Ltd,
Yongin-si Gyeonggi, KR
Align Technology, Inc.
San Jose, CA, US
510(k) clearances
34 clearances for this product code
- Hangzhou ChohoTech Co., Ltd.May 8, 2026
K260419 · LingOral Dental Design System
- Dentsply Sirona, Inc.Mar 4, 2026
K253565 · SureSmile Software
- Amv Consulting, LLCJan 7, 2026
K252507 · SmileInspector
- CelebraceDec 29, 2025
K253343 · Celebrace Software
- Laon Medi, Inc.Apr 23, 2025
K250198 · Laon Ortho
- Progressive Aligners, Inc.Oct 11, 2024
K241153 · Progressive Orthodontics App
- Ray Co., Ltd.May 16, 2024
K233625 · RAYDENT SW
- Laon Medi, Inc.Mar 12, 2024
K232564 · Align Studio