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CREOKORREKT Aligners

by Creodent Prosthetics Ltd

510(k) K211427

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 NumberK211427 Date13 Oct 2022ClearedStatusActive

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  • Withdrawn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
FDA applicant
Creodent Prosthetics, Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

CREOKORREKT Aligners are custom-made, clear, thermoformed polyurethane and copolyester orthodontic appliances designed for sequential tooth movement. Each aligner is designed and printed with high-performance resin that delivers uniform pressure, superior accuracy, and true shape retention throughout treatment.

The aligners are supplied based on intraoral scans or PVS impressions of patient dentition, with treatment planning performed by dentists using dental design software. The device is FDA 510(k) cleared with product code NXC and is classified as a Class II medical device for dental use. No information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided in the data.

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Questions

AI-generated answers, 27 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 are CREOKORREKT Aligners used for?

    CREOKORREKT Aligners are custom-made, clear orthodontic appliances designed for sequential tooth movement. They are created from intraoral scans or PVS impressions and use high-performance resin to deliver uniform pressure throughout treatment.

  • How are CREOKORREKT Aligners supplied?

    The aligners are supplied based on intraoral scans or PVS impressions of patient dentition, with treatment planning performed by dentists using dental design software. Each aligner is designed and printed with high-performance resin.

  • What is the regulatory status of CREOKORREKT Aligners?

    CREOKORREKT Aligners are FDA 510(k) cleared with product code NXC and classified as a Class II medical device for dental use. They received clearance through the traditional review process with decision code SESE.

  • What materials are used in CREOKORREKT Aligners?

    The aligners are made from thermoformed polyurethane and copolyester materials. They are designed and printed with high-performance resin that delivers uniform pressure, superior accuracy, and true shape retention throughout treatment.