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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
FOIA Releasable 510(k) K122753
Device Name EMPOWER CLEAR
Applicant
AMERICAN ORTHODONTICS
1536 N. 18TH ST.
SHEBOYGAN,  WI  53081
Applicant Contact TRANG ADAMS
Correspondent
AMERICAN ORTHODONTICS
1536 N. 18TH ST.
SHEBOYGAN,  WI  53081
Correspondent Contact TRANG ADAMS
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/07/2012
Decision Date 12/14/2012
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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