URIS OMNI System

Implant, Endosseous, Root-form

TruAbutment Inc.

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

Pre-market Notification Details

Device IDK172100
510k NumberK172100
Device Name:URIS OMNI System
ClassificationImplant, Endosseous, Root-form
Applicant TruAbutment Inc. 300 South Harbor Blvd #520 Anaheim,  CA  92805
ContactBrandon Kim
CorrespondentApril Lee
WithUS Group Inc 106 Superior Irvine,  CA  92620
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-11
Decision Date2018-05-04
Summary:summary

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