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ClearPath Aligner

by Clearpath Orthodontics, Ltd. Pakistan 510(k)

510(k) K162609

Product code NXC

Overview

The ClearPath Aligner is a dental aligner device used for orthodontic treatment. It is a sequential aligner system designed to move teeth into proper alignment.

The ClearPath Aligner is supplied as a dental device and is regulated under FDA 510K clearance with device class 2. It is manufactured by Clearpath Orthodontics, Ltd. and is available in various sizes as indicated by the multiple registration numbers provided.

Summary written by AI from registry data, 6 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162609 Date6 Jul 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
NXC
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Clearpath Orthodontics, Ltd.

Questions

  • What is the ClearPath Aligner used for?

    The ClearPath Aligner is a dental aligner device designed for orthodontic treatment. It functions as a sequential aligner system that moves teeth into proper alignment over time.

  • How is the ClearPath Aligner supplied?

    The ClearPath Aligner is supplied as a dental device manufactured by Clearpath Orthodontics, Ltd. It is available in various sizes as indicated by the multiple registration numbers provided.

  • What is the regulatory status of the ClearPath Aligner?

    The ClearPath Aligner is regulated under FDA 510K clearance with device class 2. It received FDA clearance through the traditional clearance process with a decision code of SESE, indicating it is substantially equivalent to other devices.

  • Is the ClearPath Aligner single-use or reusable?

    The device data does not specify whether the ClearPath Aligner is single-use or reusable. This information would typically be provided in the product's instructions for use or labeling.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K162609 24 fields · synced 22 Oct 2026