# Smilers Aligner

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/smilers-nxc>
- Manufacturer: [Biotech Dental Smilers](https://devicerts.com/manufacturers/biotech-dental-smilers) (France)
- Name in the registry: SMILERS
- Device class: Class II (US FDA)
- FDA product code: NXC

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Smilers Aligner is a custom-made, Class IIa medical device designed for sequential dental alignment. It consists of transparent thermoplastic aligners used to gradually reposition teeth into desired positions, addressing orthodontic concerns through a series of incremental adjustments.

These aligners are supplied as single-use, sterile devices tailored to individual patient needs. They are intended for use in dental offices and require proper storage under controlled conditions to maintain sterility. The device is regulated under FDA 510K clearance (K212961) and complies with regulation number 872.5470, with no specific MRI safety restrictions noted.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K212961 · decision 2021-09-20 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K212961 [FDA 510(k)]
- FDA product code: NXC [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 872.5470 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Smilers Aligner, Biotech Dental Smilers. deviCERTS medical device catalogue. https://devicerts.com/devices/smilers-nxc (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/smilers-nxc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/smilers-nxc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.