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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 K200908
Device Name iSMILE
Applicant
3D Diagnostix, Inc.
24 Denby Rd.
Allston,  MA  02134
Applicant Contact Ehab Amin
Correspondent
3D Diagnostix, Inc.
24 Denby Rd.
Allston,  MA  02134
Correspondent Contact Ehab Amin
Regulation Number872.5470
Classification Product Code
NXC  
Date Received04/06/2020
Decision Date 12/22/2020
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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