Bio-TackS Orthodontic Mini Implant

Implant, Endosseous, Orthodontic

Bio Cetec Co., Ltd.

The following data is part of a premarket notification filed by Bio Cetec Co., Ltd. with the FDA for Bio-tacks Orthodontic Mini Implant.

Pre-market Notification Details

Device IDK190871
510k NumberK190871
Device Name:Bio-TackS Orthodontic Mini Implant
ClassificationImplant, Endosseous, Orthodontic
Applicant Bio Cetec Co., Ltd. RM 1001-1002 New T Castle, 108, Gasan Digital 2-ro Geumcheon-gu Seoul,  KR 08506
ContactHee Sue Jin
CorrespondentDave Kim
MTech Group Inc. 8310 Buffalo Speedway Houston,  TX  77025
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-03
Decision Date2020-01-17

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