Argen Clear Aligner, Argen Clear Aligner Premium

FDA 510(k) K192846 · Argen Corporation

Substantially Equivalent

510(k) numberK192846

Submission

Device name
Argen Clear Aligner, Argen Clear Aligner Premium
Applicant
Argen Corporation
San Diego, CA, US
Received
October 3, 2019
Decision date
February 10, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 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.

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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

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Questions and answers

When was Argen Clear Aligner, Argen Clear Aligner Premium cleared by the FDA?

Argen Clear Aligner, Argen Clear Aligner Premium (K192846) received a 510(k) decision of Substantially Equivalent on February 10, 2020, 130 days after the submission was received.

What is the product code of K192846?

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