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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 K173784
Device Name Smylic Invisible Clear Aligners
Applicant
Smylio, Inc
48890 Milmont Drive
Fremont,  CA  94538
Applicant Contact Ken Menon
Correspondent
JCQ Consulting
11218 Zest Court NE
Blaine,  MN  55449
Correspondent Contact Bill Jacqmein
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/13/2017
Decision Date 08/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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