S-Clean SQ-SL Implant System Regular

Implant, Endosseous, Root-form

Dentis Co., Ltd.

The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Sq-sl Implant System Regular.

Pre-market Notification Details

Device IDK192688
510k NumberK192688
Device Name:S-Clean SQ-SL Implant System Regular
ClassificationImplant, Endosseous, Root-form
Applicant Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu,  KR 42718
ContactGyu Ri Kim
CorrespondentApril Lee
Withus Group Inc. 106 Superior Irvine,  CA  92620
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-02-04

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