S-Clean Pre-Milled Abutment

Abutment, Implant, Dental, Endosseous

Dentis Co., Ltd.

The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Pre-milled Abutment.

Pre-market Notification Details

Device IDK210362
510k NumberK210362
Device Name:S-Clean Pre-Milled Abutment
ClassificationAbutment, Implant, Dental, Endosseous
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 CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-08-19

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