PNNClass II

Orthodontic Software

21 CFR 872.5470 / Dental

PNN is the FDA product code for Orthodontic Software, a class II device type, regulated under 21 CFR 872.5470. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 34 510(k) clearances under this code, the most recent dated 2026-05-08, and 2 recalls.

Classification record

Product code: PNN
Device name: Orthodontic Software
FDA definition: 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.
Regulation: 21 CFR 872.5470
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 35
Ingested recalls: 2

Clearances, product code PNN

By decision year

35 clearances under product code PNN with a decision year between 2016 and 2026, 2020 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code PNN by decision year
Year	Clearances
2016	1
2017	2
2018	5
2019	2
2020	7
2021	4
2022	1
2023	3
2024	4
2025	2
2026	4

Applicants with the most clearances

Product code PNN

Applicants holding the most 510(k) clearances under product code PNN
Applicant	Clearances
3Shape A/S	5
Dentsply Sirona Inc	2
Laon Medi Inc.	2
Software Nemotec, S.L.	2
uLab Systems, Inc	2
Align Technology, Inc.	1
Amv Consulting, LLC	1
Archform, Inc.	1
BRIUS Technologies Inc.	1
CDB Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order