OneQ-SL S-Clean Implant System

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 Oneq-sl S-clean Implant System.

Pre-market Notification Details

Device IDK153639
510k NumberK153639
Device Name:OneQ-SL S-Clean Implant System
ClassificationImplant, Endosseous, Root-form
Applicant DENTIS CO., LTD. 99, SEONGSEOSEO-RO, DALSEO-GU Daegu,  KR 41718
ContactSun Chul Shin
CorrespondentApril Lee
Withus Group Inc 2531 Pepperdale Drive Rowland Heights,  CA  91748
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-04-08
Summary:summary

NIH GUDID Devices

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