TruAbutment DS, TruBase S

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, Trubase S.

Pre-market Notification Details

Device IDK201197
510k NumberK201197
Device Name:TruAbutment DS, TruBase S
ClassificationAbutment, Implant, Dental, Endosseous
Applicant TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
ContactEunjin Jang
CorrespondentChris Choi
TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2021-03-26

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