FDA.report

510(k) K250343

Device
LuxCreo Clear Aligner System
Applicant
LuxCreo, Inc.
510(k) number
K250343
Product code
NXC
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-08
Date received
2025-02-06
Regulation
872.5470
Classification name
Aligner, Sequential
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Tao Feng
Address
350 W. Ontario St., Suite 700 Chicago IL US 60654 60654

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00860013903114LuxCreo Clear Aligner SystemLuxcreo Inc2025-04-18
00860013903107LuxCreo Clear Aligner SystemLuxcreo Inc2025-04-18

Other 510(k) Records For Product Code NXC

510(k)DeviceApplicantDecision date
K260788Smylio AlignersSmylio, Inc.2026-05-08
K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.2026-04-15
K253282ZSmile SystemDror Orthodesign , Ltd.2026-02-03
K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited2026-01-07
K250739Primeprint Direct AlignerDreve Dentamid GmbH2025-11-07
K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.2025-10-23
K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.2025-10-09
K251758Serafin®Tns Co., Ltd.2025-09-11
K252380Invisalign SystemAlign Technology, Inc.2025-08-29
K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.2025-08-27
K251616Clear MiracleOds Co., Ltd.2025-07-22
K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.2025-05-21
K250487SparkTM Clear Aligner SystemOrmco Corporation2025-02-20
K242715Pearl Clear AlignerPearl Digital, Inc.2025-01-16
K242929Fas Aligner SystemXplora 3D Europe S.L2024-12-20