TruAbutment DS

Abutment, Implant, Dental, Endosseous

TruAbutment Inc.

The following data is part of a premarket notification filed by Truabutment Inc. with the FDA for Truabutment Ds.

Pre-market Notification Details

Device IDK191913
510k NumberK191913
Device Name:TruAbutment DS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
ContactKiyoon Nam
CorrespondentChris Choi
TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-17
Decision Date2020-06-19

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