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ClearPath Aligner

by Qserve America, Inc.

510(k) K123514

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123514 Date1 Nov 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ClearPath Aligner is a Sequential Aligner (Device Type: NXC), a removable orthodontic appliance designed to gradually reposition teeth. It consists of a series of custom-fabricated, clear, thermoformed plastic aligners used for minor anterior tooth movement, typically in dental alignment therapy.

These aligners are fabricated based on dental impressions taken by a clinician and are intended for single-use per stage of treatment. The device is classified as Class II under FDA regulation 872.5470, with a 510(k) clearance (K123514) granted under the Dental Advisory Committee in 2013. Supplied as a reusable mold system for sequential aligner fabrication, it requires no sterilization as it is not directly patient-contacting beyond impression capture.

Other devices from Qserve America, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of tooth movements can the ClearPath Aligner address, and how does it differ from traditional braces?

    The ClearPath Aligner is specifically designed for minor anterior tooth movement, meaning it focuses on repositioning front teeth rather than comprehensive orthodontic corrections. Unlike traditional braces, which use fixed wires and brackets, this device uses a series of removable, clear plastic aligners that gradually shift teeth into place. Each aligner is custom-made based on dental impressions and is intended for single-use per stage of treatment, allowing for gradual adjustments over time.

  • Is the ClearPath Aligner system reusable, and if so, how should the reusable components be handled?

    The ClearPath Aligner system includes a reusable mold system used for fabricating the sequential aligners, but the aligners themselves are single-use per stage of treatment. The reusable mold system is not directly patient-contacting beyond capturing dental impressions, so it does not require sterilization. Proper handling involves cleaning the mold system as instructed by the manufacturer to maintain its integrity for subsequent aligner fabrication.

  • How are the ClearPath Aligner stages customized, and what role does the clinician play in this process?

    Customization of the ClearPath Aligner stages begins with dental impressions taken by the clinician. These impressions are used to fabricate a series of custom-fabricated, clear plastic aligners tailored to the patient’s specific tooth alignment needs. The clinician determines the sequence and progression of aligners based on the treatment plan, ensuring gradual and precise tooth movement throughout the therapy.

  • What regulatory pathway was followed for the FDA clearance of the ClearPath Aligner, and what does this mean for clinicians?

    The ClearPath Aligner received FDA 510(k) clearance (K123514) under the Dental Advisory Committee (DE) in 2013, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the device was evaluated for safety and effectiveness compared to existing aligners and was classified as Class II, requiring pre-market notification to the FDA. Clinicians can rely on this clearance as evidence of the device’s compliance with FDA standards for sequential aligners.

  • Are there specific storage requirements for the ClearPath Aligner system or the custom aligners?

    The ClearPath Aligner system’s reusable mold components should be stored in a clean, dry environment to prevent contamination or damage. Since the aligners themselves are single-use and typically provided by the manufacturer after fabrication, they do not require long-term storage by the clinician. However, unopened aligners should be kept in their original packaging until ready for use, following the manufacturer’s instructions to maintain sterility and integrity.