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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K122753
Device Name EMPOWER CLEAR
Original Applicant
AMERICAN ORTHODONTICS
1536 n. 18th st.
sheboygan,  WI  53081
Original Contact trang adams
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/12/2012
Decision Date 12/14/2012
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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