FDA product code PNN: Orthodontic Software
PNN is the FDA product code for orthodontic software. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 34 510(k) submissions under PNN, 13 in the last five years, from 27 different applicants. The average 510(k) review took 162 days (median 166); 120 days on average over the last three years. FDA has posted 2 recalls for PNN devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Orthodontic Software |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PNN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 139 |
| 2018 | 5 | 233 |
| 2019 | 2 | 194 |
| 2020 | 7 | 210 |
| 2021 | 4 | 57 |
| 2022 | 1 | 197 |
| 2023 | 3 | 118 |
| 2024 | 4 | 153 |
| 2025 | 2 | 90 |
| 2026 | 3 | 116 |
Compare with all 510(k) review times · Search every PNN clearance
Top PNN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3Shape A/S | 5 | 2019-11-27 |
| Laon Medi, Inc. | 2 | 2025-04-23 |
| Software Nemotec S.L. | 2 | 2023-11-21 |
| Ulab Systems, Inc. | 2 | 2020-06-23 |
| Hangzhou ChohoTech Co., Ltd. | 1 | 2026-05-08 |
22 more applicants have PNN clearances. See the full list in Caduvo.
Most recent PNN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260419 | Hangzhou ChohoTech Co., Ltd. | LingOral Dental Design System | 2026-05-08 | 88 |
| K253565 | Dentsply Sirona, Inc. | SureSmile Software | 2026-03-04 | 107 |
| K252507 | Amv Consulting, LLC | SmileInspector | 2026-01-07 | 152 |
| K253343 | Celebrace | Celebrace Software | 2025-12-29 | 90 |
| K250198 | Laon Medi, Inc. | Laon Ortho | 2025-04-23 | 90 |
Recalls for PNN devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-12-05.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code PNN?
PNN is the FDA product code for orthodontic software. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is PNN?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNN?
Across 34 cleared submissions the average was 162 days from receipt to decision (median 166).
Which companies have the most PNN clearances?
3Shape A/S (5); Laon Medi, Inc. (2); Software Nemotec S.L. (2); Ulab Systems, Inc. (2); Hangzhou ChohoTech Co., Ltd. (1).
Have PNN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code PNN
- Run a recall and safety report across every PNN manufacturer
- Watch product code PNN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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