CREOKORREKT Aligners

FDA 510(k) K211427 · Creodent Prosthetics, Ltd.

Substantially Equivalent

510(k) numberK211427

Submission

Device name
CREOKORREKT Aligners
Applicant
Creodent Prosthetics, Ltd.
New York, NY, US
Received
May 7, 2021
Decision date
October 13, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NXC – Aligner, Sequential
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other 510(k)s with product code NXC

510(k)DeviceApplicantDecision
K260527FACE4D AlignerNXC · Traditional Avinent Implant System S.L.U.07/02/2026SE
K260788Smylio AlignersNXC · Traditional Smylio, Inc.05/08/2026SE
K260722SureSmile Aligner (ASSY500020)NXC · Traditional Dentsply Sirona, Inc.04/15/2026SE
K253282ZSmile SystemNXC · Special Dror Orthodesign , Ltd.02/03/2026SE
K251454Clear Aligner (SCF-3348)NXC · Traditional Beame Medical Technology (Shenzhen) Limited01/07/2026SE
K250739Primeprint Direct AlignerNXC · Traditional Dreve Dentamid GmbH11/07/2025SE
K252931Invisalign® Palatal Expander SystemNXC · Special Align Technology, Inc.10/23/2025SE
K252870Invisalign Specifix Attachment SystemNXC · Special Align Technology, Inc.10/09/2025SE
K251758Serafin®NXC · Traditional Tns Co., Ltd.09/11/2025SE
K252380Invisalign SystemNXC · Special Align Technology, Inc.08/29/2025SE

More from Align Technology, Inc.

510(k)DeviceDecision
K220390CreoDent Solidex Customized Abutment and ScrewNHA · Traditional 12/02/2022SE
K202909CreoDent Solidex Customized AbutmentNHA · Special 04/02/2021SE
K202095CreoDent Solidex Customized Abutment and ScrewNHA · Traditional 12/16/2020SE
K170100CreoDent Solidex Customized Abutment and ScrewNHA · Traditional 07/18/2017SE
K162734CreoDent Solidex Customized AbutmentNHA · Traditional 05/08/2017SE
K160436CreoDent Solidex Custom AbutmentNHA · Traditional 09/29/2016SE
K150012CreoDent Solidex Customized AbutmentNHA · Traditional 06/04/2015SE
K113738Creodent Solidex Custom AbutmentNHA · Traditional 09/17/2013SE

Questions and answers

When was CREOKORREKT Aligners cleared by the FDA?

CREOKORREKT Aligners (K211427) received a 510(k) decision of Substantially Equivalent on October 13, 2022, 524 days after the submission was received.

What is the product code of K211427?

The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.