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 IDK213961
510k NumberK213961
Device Name:TruAbutment DS, TruBase
ClassificationAbutment, Implant, Dental, Endosseous
Applicant TruAbutment Inc. 17666 Fitch Irvine,  CA  92614
ContactHyeonhwa An
CorrespondentChris Choi
TruAbutment Inc. 17666 Fitch Irvine,  CA  92614
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-07-14

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