← Product Code [NXC](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC) · K260722

# SureSmile Aligner (ASSY500020) (K260722)

_Dentsply Sirona, Inc. · NXC · Apr 15, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K260722

## Device Facts

- **Applicant:** Dentsply Sirona, Inc.
- **Product Code:** [NXC](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC.md)
- **Decision Date:** Apr 15, 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K260722](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/NXC/K260722)

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