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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 K090567
Device Name ORTHODONTIC CERAMIC BRACKET
Applicant
STAR DENTECH KOREA., CORP
49 CANDLEWOOD WAY
BUENA PARK,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
STAR DENTECH KOREA., CORP
49 CANDLEWOOD WAY
BUENA PARK,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number872.5470
Classification Product Code
NJM  
Date Received03/03/2009
Decision Date 05/27/2009
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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