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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K260421
Device Name LuxDesign
Applicant
LuxCreo, Inc.
350 W. Ontario St., Suite 700
Chicago,  IL  60654
Applicant Contact Feng Tao
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.,Lt
Rm. 1509, Jingting Bldg., Dongzhou Community
Guangming St., Guangming District
Shenzhen,  CN
Correspondent Contact Reanny Wang
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received02/09/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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