Healing Abutments And Cover Screws

Abutment, Implant, Dental, Endosseous

Dentium Co., Ltd.

The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Healing Abutments And Cover Screws.

Pre-market Notification Details

Device IDK192436
510k NumberK192436
Device Name:Healing Abutments And Cover Screws
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Dentium Co., Ltd. 150, Eondong-ro Giheung-gu Yongin-si,  KR 446-914
ContactByung-sun Kim
CorrespondentByung-sun Kim
Dentium Co., Ltd. 150, Eondong-ro Giheung-gu Yongin-si,  KR 446-914
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-06
Decision Date2020-01-23
Summary:summary

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