Smylio Aligners

FDA 510(k) K260788 · Smylio, Inc.

Substantially Equivalent

510(k) numberK260788

Submission

Device name
Smylio Aligners
Applicant
Smylio, Inc.
Fremont, CA, US
Received
March 10, 2026
Decision date
May 8, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
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

More from Aidite (Qinhuangdao) Technology Co., Ltd.

510(k)DeviceDecision
K221537Nightwear AlignersNXC · Traditional 04/05/2023SE
K212660Smylio Invisible Clear AlignersNXC · Special 09/22/2021SE
K173784Smylic Invisible Clear AlignersNXC · Traditional 08/23/2018SE

Questions and answers

When was Smylio Aligners cleared by the FDA?

Smylio Aligners (K260788) received a 510(k) decision of Substantially Equivalent on May 8, 2026, 59 days after the submission was received.

What is the product code of K260788?

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