TruAbutment DS, TruBase

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.

Pre-market Notification Details

Device IDK202579
510k NumberK202579
Device Name:TruAbutment DS, TruBase
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2021-07-08

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