Fit & Brilliant Dental Implant System

Implant, Endosseous, Root-form

F&B Technology Co., Ltd.

The following data is part of a premarket notification filed by F&b Technology Co., Ltd. with the FDA for Fit & Brilliant Dental Implant System.

Pre-market Notification Details

Device IDK190637
510k NumberK190637
Device Name:Fit & Brilliant Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant F&B Technology Co., Ltd. 17-230, #37, Kwaegam-ro, Sasang-ku, (Kwaebop, Ind. Supplies Market) Busan,  KR 46977
ContactJ H An
CorrespondentHo Dong Yang
Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul,  KR 46977
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-12
Decision Date2020-06-19

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