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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 K121396
Device Name DYNAFLEX
Original Applicant
DYNA FLEX
10403 international plaza dr.
northwest plaza,  MO  63074
Original Contact matthew malabey
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/09/2012
Decision Date 08/14/2012
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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