C-Line Orthodontic Ceramic Bracket

Bracket, Ceramic, Orthodontic

BIOCETEC CO., LTD

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

Pre-market Notification Details

Device IDK163467
510k NumberK163467
Device Name:C-Line Orthodontic Ceramic Bracket
ClassificationBracket, Ceramic, Orthodontic
Applicant BIOCETEC CO., LTD RM 3-952AB, H1-DONG, KIST,5, HWARANG-RO 14-GIL (HAWOLGOK-DONG 39-1) Seoul,  KR
ContactDave Kim
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-12
Decision Date2017-06-14
Summary:summary

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