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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 K163155
Device Name MTM Clear Aligner
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60
York,  PA  17408
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60
York,  PA  17408
Correspondent Contact HELEN LEWIS
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/10/2016
Decision Date 02/03/2017
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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