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 IDK172304
510k NumberK172304
Device Name:TruAbutment DS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant TruAbutment Inc. 300 South Harbor Blvd #520 Anaheim,  CA  92805
ContactBrandon Kim
CorrespondentApril Lee
Withus Group Inc 2531 Pepperdale Drive Rowland Heights,  CA  91748
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2018-01-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.