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) → NXC — Aligner, Sequential

# NXC · Aligner, Sequential

_Dental · 21 CFR 872.5470 · Class 2_

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

## Overview

- **Product Code:** NXC
- **Device Name:** Aligner, Sequential
- **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 144)

Showing 20 most recent of 144 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260788](/device/K260788.md) | Smylio Aligners | Smylio, Inc. | May 8, 2026 | SESE |
| [K260722](/device/K260722.md) | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | Apr 15, 2026 | SESE |
| [K253282](/device/K253282.md) | ZSmile System | Dror Orthodesign , Ltd. | Feb 3, 2026 | SESE |
| [K251454](/device/K251454.md) | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | Jan 7, 2026 | SESE |
| [K250739](/device/K250739.md) | Primeprint Direct Aligner | Dreve Dentamid GmbH | Nov 7, 2025 | SESE |
| [K252931](/device/K252931.md) | Invisalign® Palatal Expander System | Align Technology, Inc. | Oct 23, 2025 | SESE |
| [K252870](/device/K252870.md) | Invisalign Specifix Attachment System | Align Technology, Inc. | Oct 9, 2025 | SESE |
| [K251758](/device/K251758.md) | Serafin® | Tns Co., Ltd. | Sep 11, 2025 | SESE |
| [K252380](/device/K252380.md) | Invisalign System | Align Technology, Inc. | Aug 29, 2025 | SESE |
| [K251415](/device/K251415.md) | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | Aug 27, 2025 | SESE |
| [K251616](/device/K251616.md) | Clear Miracle | Ods Co., Ltd. | Jul 22, 2025 | SESE |
| [K242637](/device/K242637.md) | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | May 21, 2025 | SESE |
| [K250343](/device/K250343.md) | LuxCreo Clear Aligner System | LuxCreo, Inc. | Apr 8, 2025 | SESE |
| [K250487](/device/K250487.md) | SparkTM Clear Aligner System | Ormco Corporation | Feb 20, 2025 | SESE |
| [K242715](/device/K242715.md) | Pearl Clear Aligner | Pearl Digital, Inc. | Jan 16, 2025 | SESE |
| [K242929](/device/K242929.md) | Fas Aligner System | Xplora 3D Europe S.L | Dec 20, 2024 | SESE |
| [K242892](/device/K242892.md) | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | Dec 19, 2024 | SESE |
| [K233152](/device/K233152.md) | GENIOVA aligners | Geniova Technologies Sociedad Limitada | Dec 12, 2024 | SESE |
| [K240501](/device/K240501.md) | Spark™ Clear Aligner System | Ormco Corporation | Oct 11, 2024 | SESE |
| [K233356](/device/K233356.md) | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | Aug 8, 2024 | SESE |

## Top Applicants

- Align Technology, Inc. — 10 clearances
- Smylio, Inc. — 4 clearances
- 3M Company, Unitek Orthodontic Products — 3 clearances
- Blue Sky Bio, LLC — 3 clearances
- Ormco Corporation — 3 clearances

---

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

**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