SNUCONE Bone Level Implant System

Implant, Endosseous, Root-form

SNUCONE Co., LTD.

The following data is part of a premarket notification filed by Snucone Co., Ltd. with the FDA for Snucone Bone Level Implant System.

Pre-market Notification Details

Device IDK210354
510k NumberK210354
Device Name:SNUCONE Bone Level Implant System
ClassificationImplant, Endosseous, Root-form
Applicant SNUCONE Co., LTD. 5, Seongseo-ro 75-gil Dalseo-gu,  KR 42703
ContactJi Eun Song
CorrespondentSanglok Lee
Wise Company Inc. #507, #508, 166 Gasan Digital 2-ro Geumcheon-gu,  KR 08503
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2022-07-13

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