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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 K212660
Device Name Smylio Invisible Clear Aligners
Applicant
Smylio, Inc
48890 Milmont Dr.
Fremont,  CA  94538
Applicant Contact Ren Menon
Correspondent
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/23/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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