PNN — Orthodontic Software Class II
Classification Details
- Product Code
- PNN
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253565 | dentsply sirona | SureSmile Software | March 4, 2026 |
| K252507 | amv consulting | SmileInspector | January 7, 2026 |
| K253343 | celebrace | Celebrace Software | December 29, 2025 |
| K250198 | laon medi | Laon Ortho | April 23, 2025 |
| K241153 | progressive aligners | Progressive Orthodontics App | October 11, 2024 |
| K233625 | ray co | RAYDENT SW | May 16, 2024 |
| K232564 | laon medi | Align Studio | March 12, 2024 |
| K233616 | clevaligner | Clevaligner Software (V1.0.0) | January 11, 2024 |
| K232549 | software nemotec s.l | NemoCast | November 21, 2023 |
| K232429 | clearadvance | Titan Dental Design | October 13, 2023 |
| K223518 | shanghai ea medical instruments co | iOrtho | June 13, 2023 |
| K212173 | cdb corporation | HDH Treatment Planning System | January 25, 2022 |
| K212770 | softsmile | Vision | December 21, 2021 |
| K213916 | archform | ArchForm Orthodontic Software System | December 16, 2021 |
| K212828 | brius technologies | BRIUS Planner Software | October 1, 2021 |
| K203442 | swift health systems | Inbrace Orthodontic System | February 19, 2021 |
| K201036 | choice biotech | PlaniMax Orthodontic Software | December 22, 2020 |
| K192847 | diorco co | AUTOLIGN | July 21, 2020 |
| K200772 | ulab systems | ULab Systems uDesign Software | June 23, 2020 |
| K193003 | software nemotec s.l | NemoCast | June 5, 2020 |