← Product Code [PNN](/productcode/PNN) · K262196

# Invisalign System (K262196)

_Align Technology, Inc. · PNN · Sep 25, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262196

## Device Facts

- **Applicant:** Align Technology, Inc.
- **Product Code:** [PNN](/productcode/PNN.md)
- **Decision Date:** Sep 25, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5470
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/device/K262196](https://fda.innolitics.com/device/K262196)

**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