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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 K190583
Device Name DynaFlex
Applicant
Dyna Flex
10403 International Plaza Dr.
St. Ann,  MO  63074
Applicant Contact Matthew Malabey
Correspondent
Dyna Flex
10403 International Plaza Dr.
St. Ann,  MO  63074
Correspondent Contact Matthew Malabey
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/06/2019
Decision Date 06/27/2019
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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