Nightwear Aligners

FDA 510(k) K221537 · Smylio, Inc.

Substantially Equivalent

510(k) numberK221537

Submission

Device name
Nightwear Aligners
Applicant
Smylio, Inc.
Fremont, CA, US
Received
May 27, 2022
Decision date
April 5, 2023
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
K260788Smylio AlignersNXC · Traditional 05/08/2026SE
K212660Smylio Invisible Clear AlignersNXC · Special 09/22/2021SE
K173784Smylic Invisible Clear AlignersNXC · Traditional 08/23/2018SE

Questions and answers

When was Nightwear Aligners cleared by the FDA?

Nightwear Aligners (K221537) received a 510(k) decision of Substantially Equivalent on April 5, 2023, 313 days after the submission was received.

What is the product code of K221537?

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