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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 K102561
Device Name ORTHODONTIC CERAMIC BRACKET
Applicant
Ht Co., Ltd.
Hbi 527, Hanyang Univ.
1271 Sa 1(Il)-Dong Sangnok-Gu
Ansan-Si, Gyeonggi-Do,  KR 426-791
Applicant Contact JERRY CHOI
Correspondent
Ht Co., Ltd.
Hbi 527, Hanyang Univ.
1271 Sa 1(Il)-Dong Sangnok-Gu
Ansan-Si, Gyeonggi-Do,  KR 426-791
Correspondent Contact JERRY CHOI
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/07/2010
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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