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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K253365
Device Name LuxCreo Flexible Partial Denture Resin
Applicant
Luxcreo, Inc.
350 W. Ontario St., Suite 700
Chicago,  IL  60654
Applicant Contact Tao Feng
Correspondent
Luxcreo, Inc.
350 W. Ontario St., Suite 700
Chicago,  IL  60654
Correspondent Contact Tao Feng
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/30/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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