ATOZ Mini-Screw

Implant, Endosseous, Orthodontic

MK Meditech Inc.

The following data is part of a premarket notification filed by Mk Meditech Inc. with the FDA for Atoz Mini-screw.

Pre-market Notification Details

Device IDK210559
510k NumberK210559
Device Name:ATOZ Mini-Screw
ClassificationImplant, Endosseous, Orthodontic
Applicant MK Meditech Inc. Room# 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si,  KR 13449
ContactSungchul Moon
CorrespondentSungchul Moon
MK Meditech Inc. Room# 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si,  KR 13449
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-12-19

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