Additively Manufactured Aligner Resin

FDA 510(k) K251415 · Aidite (Qinhuangdao) Technology Co., Ltd.

Substantially Equivalent

510(k) numberK251415

Submission

Device name
Additively Manufactured Aligner Resin
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao, CN
Received
May 7, 2025
Decision date
August 27, 2025
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
K253036Light-curing Coloring Materials (ALCM)EBF · Traditional 04/06/2026SE
K250534Biomic Color OpaqueEIH · Traditional 05/20/2025SE
K250497Additive Manufacturing (Light Curing) Crown Bridge ResinEBF · Traditional 04/30/2025SE
K250811Dental Zirconia CeramicEIH · Special 04/11/2025SE
K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIH · Traditional 03/14/2025SE
K242884Additively Manufactured Denture ResinEBI · Traditional 11/22/2024SE
K241715Dental Glass Ceramics Blocks (HT,LT,ST)EIH · Special 07/12/2024SE
K230115Denture Base ResinEBI · Traditional 03/17/2023SE
K223742Dental Ceramic BlocksEBF · Traditional 03/08/2023SE
K223477PMMA Blocks for Dental UseEBG · Traditional 02/16/2023SE

Questions and answers

When was Additively Manufactured Aligner Resin cleared by the FDA?

Additively Manufactured Aligner Resin (K251415) received a 510(k) decision of Substantially Equivalent on August 27, 2025, 112 days after the submission was received.

What is the product code of K251415?

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