Pre-Milled Blank

Abutment, Implant, Dental, Endosseous

Arum Dentistry Co. Ltd

The following data is part of a premarket notification filed by Arum Dentistry Co. Ltd with the FDA for Pre-milled Blank.

Pre-market Notification Details

Device IDK193425
510k NumberK193425
Device Name:Pre-Milled Blank
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Arum Dentistry Co. Ltd 1 Building, 44, Techno 8-ro Yuseong-gu, Daejeon,  KR 34028
ContactHwang-heung Yeon
CorrespondentChris Brown
Aclivi, Llc 6455 Farley Road Pinckney,  MI  48169
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-10
Decision Date2020-03-09

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