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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K260788
Device Name Smylio Aligners
Applicant
Smylio, Inc.
48890 Milmont Dr. Suite 101d
Fremont,  CA  94538
Applicant Contact Ren Menon
Correspondent
Prime Path Medtech
539 W. Commerce St. #5446
Dallas,  TX  75208
Correspondent Contact Kole Villescas
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/10/2026
Decision Date 05/08/2026
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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