ORTHODONTIC CERAMIC BRACKET

Bracket, Ceramic, Orthodontic

HT CO., LTD.

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

Pre-market Notification Details

Device IDK102561
510k NumberK102561
Device Name:ORTHODONTIC CERAMIC BRACKET
ClassificationBracket, Ceramic, Orthodontic
Applicant HT CO., LTD. HBI 527, HANYANG UNIV. 1271 SA 1(IL)-DONG SANGNOK-GU Ansan-si, Gyeonggi-do,  KR 426-791
ContactJerry Choi
CorrespondentJerry Choi
HT CO., LTD. HBI 527, HANYANG UNIV. 1271 SA 1(IL)-DONG SANGNOK-GU Ansan-si, Gyeonggi-do,  KR 426-791
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-07
Decision Date2011-01-25
Summary:summary

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