FACE4D Aligner

FDA 510(k) K260527 · Avinent Implant System S.L.U.

Substantially Equivalent

510(k) numberK260527

Submission

Device name
FACE4D Aligner
Applicant
Avinent Implant System S.L.U.
Barcelona, ES
Received
February 17, 2026
Decision date
July 2, 2026
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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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
K251415Additively Manufactured Aligner ResinNXC · Traditional Aidite (Qinhuangdao) Technology Co., Ltd.08/27/2025SE

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Questions and answers

When was FACE4D Aligner cleared by the FDA?

FACE4D Aligner (K260527) received a 510(k) decision of Substantially Equivalent on July 2, 2026, 135 days after the submission was received.

What is the product code of K260527?

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