PNN · Class II · 21 CFR 872.5470

FDA Product Code PNN: 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.

Leading manufacturers include 3Shape A/S, Ulab Systems, Inc. and Laon Medi, Inc..

34
Total
34
Cleared
162d
Avg days
2016
Since
Stable submission activity - 6 submissions in the last 2 years
Review times improving: avg 116d recently vs 172d historically

FDA 510(k) Cleared Orthodontic Software Devices (Product Code PNN)

34 devices
1–24 of 34
Cleared May 08, 2026
LingOral Dental Design System
K260419
Hangzhou ChohoTech Co., Ltd.
Dental · 88d
Cleared Mar 04, 2026
SureSmile Software
K253565
Dentsply Sirona, Inc.
Dental · 107d
Cleared Jan 07, 2026
SmileInspector
K252507
Amv Consulting, LLC
Dental · 152d
Cleared Dec 29, 2025
Celebrace Software
K253343
Celebrace
Dental · 90d
Cleared Apr 23, 2025
Laon Ortho
K250198
Laon Medi, Inc.
Dental · 90d
Cleared Oct 11, 2024
Progressive Orthodontics App
K241153
Progressive Aligners, Inc.
Dental · 168d
Cleared May 16, 2024
RAYDENT SW
K233625
Ray Co., Ltd.
Dental · 185d
Cleared Mar 12, 2024
Align Studio
K232564
Laon Medi, Inc.
Dental · 201d
Cleared Jan 11, 2024
Clevaligner Software (V1.0.0)
K233616
Clevaligner, Ltd.
Dental · 59d
Cleared Nov 21, 2023
NemoCast
K232549
Software Nemotec S.L.
Dental · 90d
Cleared Oct 13, 2023
Titan Dental Design
K232429
Clearadvance, LLC
Dental · 63d
Cleared Jun 13, 2023
iOrtho
K223518
Shanghai EA Medical Instruments Co., Ltd.
Dental · 202d
Cleared Jan 25, 2022
HDH Treatment Planning System
K212173
Cdb Corporation
Dental · 197d
Cleared Dec 21, 2021
Vision
K212770
Softsmile, Inc.
Dental · 112d
Cleared Dec 16, 2021
ArchForm Orthodontic Software System
K213916
Archform, Inc.
Dental · 1d
Cleared Oct 01, 2021
BRIUS Planner Software
K212828
Brius Technologies, Inc.
Dental · 28d
Cleared Feb 19, 2021
Inbrace Orthodontic System
K203442
Swift Health Systems, Inc.
Dental · 88d
Cleared Dec 22, 2020
PlaniMax Orthodontic Software
K201036
Choice Biotech, Inc.
Dental · 246d
Cleared Jul 21, 2020
AUTOLIGN
K192847
Diorco Co., Ltd.
Dental · 292d
Cleared Jun 23, 2020
ULab Systems uDesign Software
K200772
Ulab Systems, Inc.
Dental · 90d
Cleared Jun 05, 2020
NemoCast
K193003
Software Nemotec S.L.
Dental · 221d
Cleared Apr 21, 2020
DIBS (Digital Indirect Bonding System)
K192701
Orthoselect, LLC
Dental · 207d
Cleared Apr 17, 2020
BRUIS Software Suite
K191720
Mechanodontics, Inc.
Dental · 295d
Cleared Apr 02, 2020
CS Model+
K193390
Trophy
Dental · 118d

About Product Code PNN - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code PNN since 2016, with 34 receiving FDA clearance (average review time: 162 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - PNN Product Code

Recent submissions under PNN have taken an average of 116 days to reach a decision - down from 172 days historically, suggesting improved FDA processing for this classification.

PNN devices are reviewed by the Dental panel. Browse all Dental devices →