Luce Ceramic Bracket

Bracket, Ceramic, Orthodontic

Luce Castle Co., Ltd.

The following data is part of a premarket notification filed by Luce Castle Co., Ltd. with the FDA for Luce Ceramic Bracket.

Pre-market Notification Details

Device IDK201038
510k NumberK201038
Device Name:Luce Ceramic Bracket
ClassificationBracket, Ceramic, Orthodontic
Applicant Luce Castle Co., Ltd. 16, Ojeoncheon-ro, Uiwang Gyeonggi,  KR
ContactKyung Joo Kim
CorrespondentJoyce Bang-kwon
Provision Consulting Group Inc. 100 N. Barranca St Suite 700 West Covina,  CA  91791
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2020-10-09

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