URIS OMNI Narrow System & Prosthetic

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 Narrow System & Prosthetic.

Pre-market Notification Details

Device IDK200817
510k NumberK200817
Device Name:URIS OMNI Narrow System & Prosthetic
ClassificationImplant, Endosseous, Root-form
Applicant TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
ContactEunjin Jang
CorrespondentChris Choi
TruAbutment Inc. 17742 Cowan Irvine,  CA  92614
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-10-07

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