PNN · Orthodontic Software
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | PNN |
|---|---|
| Device Name | Orthodontic Software |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | Mar 4, 2026 | SESE |
| K252507 | SmileInspector | Amv Consulting, LLC | Jan 7, 2026 | SESE |
| K253343 | Celebrace Software | Celebrace | Dec 29, 2025 | SESE |
| K250198 | Laon Ortho | Laon Medi, Inc. | Apr 23, 2025 | SESE |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | Oct 11, 2024 | SESE |
| K233625 | RAYDENT SW | Ray Co., Ltd. | May 16, 2024 | SESE |
| K232564 | Align Studio | Laon Medi, Inc. | Mar 12, 2024 | SESE |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | Jan 11, 2024 | SESE |
| K232549 | NemoCast | Software Nemotec S.L. | Nov 21, 2023 | SESE |
| K232429 | Titan Dental Design | Clearadvance, LLC | Oct 13, 2023 | SESE |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | Jun 13, 2023 | SESE |
| K212173 | HDH Treatment Planning System | Cdb Corporation | Jan 25, 2022 | SESE |
| K212770 | Vision | Softsmile, Inc. | Dec 21, 2021 | SESE |
| K213916 | ArchForm Orthodontic Software System | Archform, Inc. | Dec 16, 2021 | SESE |
| K212828 | BRIUS Planner Software | Brius Technologies, Inc. | Oct 1, 2021 | SESE |
| K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | Feb 19, 2021 | SESE |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | Dec 22, 2020 | SESE |
| K192847 | AUTOLIGN | Diorco Co., Ltd. | Jul 21, 2020 | SESE |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | Jun 23, 2020 | SESE |
| K193003 | NemoCast | Software Nemotec S.L. | Jun 5, 2020 | SESE |
Top Applicants
- 3Shape A/S — 5 clearances
- Laon Medi, Inc. — 2 clearances
- Software Nemotec S.L. — 2 clearances
- Ulab Systems, Inc. — 2 clearances
- Amv Consulting, LLC — 1 clearance
