Dentis S-Clean S-Line Mini

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 Dentis S-clean S-line Mini.

Pre-market Notification Details

Device IDK210080
510k NumberK210080
Device Name:Dentis S-Clean S-Line Mini
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-12
Decision Date2021-06-04

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