Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470) → PNN — Orthodontic Software

# PNN · Orthodontic Software

_Dental · 21 CFR 872.5470 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/PNN

## Overview

- **Product Code:** PNN
- **Device Name:** Orthodontic Software
- **Regulation:** [21 CFR 872.5470](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5470)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **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 34)

Showing 20 most recent of 34 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260419](/device/K260419.md) | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | May 8, 2026 | SESE |
| [K253565](/device/K253565.md) | SureSmile Software | Dentsply Sirona, Inc. | Mar 4, 2026 | SESE |
| [K252507](/device/K252507.md) | SmileInspector | Amv Consulting, LLC | Jan 7, 2026 | SESE |
| [K253343](/device/K253343.md) | Celebrace Software | Celebrace | Dec 29, 2025 | SESE |
| [K250198](/device/K250198.md) | Laon Ortho | Laon Medi, Inc. | Apr 23, 2025 | SESE |
| [K241153](/device/K241153.md) | Progressive Orthodontics App | Progressive Aligners, Inc. | Oct 11, 2024 | SESE |
| [K233625](/device/K233625.md) | RAYDENT SW | Ray Co., Ltd. | May 16, 2024 | SESE |
| [K232564](/device/K232564.md) | Align Studio | Laon Medi, Inc. | Mar 12, 2024 | SESE |
| [K233616](/device/K233616.md) | Clevaligner Software  (V1.0.0) | Clevaligner, Ltd. | Jan 11, 2024 | SESE |
| [K232549](/device/K232549.md) | NemoCast | Software Nemotec S.L. | Nov 21, 2023 | SESE |
| [K232429](/device/K232429.md) | Titan Dental Design | Clearadvance, LLC | Oct 13, 2023 | SESE |
| [K223518](/device/K223518.md) | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | Jun 13, 2023 | SESE |
| [K212173](/device/K212173.md) | HDH Treatment Planning System | Cdb Corporation | Jan 25, 2022 | SESE |
| [K212770](/device/K212770.md) | Vision | Softsmile, Inc. | Dec 21, 2021 | SESE |
| [K213916](/device/K213916.md) | ArchForm Orthodontic Software System | Archform, Inc. | Dec 16, 2021 | SESE |
| [K212828](/device/K212828.md) | BRIUS Planner Software | Brius Technologies, Inc. | Oct 1, 2021 | SESE |
| [K203442](/device/K203442.md) | Inbrace Orthodontic System | Swift Health Systems, Inc. | Feb 19, 2021 | SESE |
| [K201036](/device/K201036.md) | PlaniMax Orthodontic Software | Choice Biotech, Inc. | Dec 22, 2020 | SESE |
| [K192847](/device/K192847.md) | AUTOLIGN | Diorco Co., Ltd. | Jul 21, 2020 | SESE |
| [K200772](/device/K200772.md) | ULab Systems uDesign Software | Ulab Systems, Inc. | Jun 23, 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

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**Source:** [https://fda.innolitics.com/productcode/PNN](https://fda.innolitics.com/productcode/PNN)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com