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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 K201038
Device Name Luce Ceramic Bracket
Applicant
Luce Castle Co., Ltd.
16, Ojeoncheon-ro, Uiwang
Gyeonggi,  KR
Applicant Contact Kyung Joo Kim
Correspondent
Provision Consulting Group Inc.
100 N. Barranca St Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Bang-Kwon
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/20/2020
Decision Date 10/09/2020
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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