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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 K080749
Device Name RADIANCE
Applicant
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Applicant Contact JEROME H SCHOMBERG
Correspondent
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Correspondent Contact JEROME H SCHOMBERG
Regulation Number872.5470
Classification Product Code
NJM  
Date Received03/17/2008
Decision Date 08/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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