Illusion Aligner Pro: Illusion Aligner FLX

FDA 510(k) K233356 · Laxmi Dental Export Pvt., Ltd.

Substantially Equivalent

510(k) numberK233356

Submission

Device name
Illusion Aligner Pro: Illusion Aligner FLX
Applicant
Laxmi Dental Export Pvt., Ltd.
Palghar, IN
Received
September 29, 2023
Decision date
August 8, 2024
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

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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

Questions and answers

When was Illusion Aligner Pro: Illusion Aligner FLX cleared by the FDA?

Illusion Aligner Pro: Illusion Aligner FLX (K233356) received a 510(k) decision of Substantially Equivalent on August 8, 2024, 314 days after the submission was received.

What is the product code of K233356?

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