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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
Model EX-ALIGN
Device Name DYNAFLEX
Applicant
DYNA FLEX
10403 international plaza dr.
northwest plaza,  MO  63074
Contact matthew malabey
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/09/2012
Decision Date 08/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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