BRIUS Planner Software

Orthodontic Software

BRIUS Technologies Inc

The following data is part of a premarket notification filed by Brius Technologies Inc with the FDA for Brius Planner Software.

Pre-market Notification Details

Device IDK212828
510k NumberK212828
Device Name:BRIUS Planner Software
ClassificationOrthodontic Software
Applicant BRIUS Technologies Inc 2611 Westgrove Dr Carrollton,  TX  75006
ContactMehdi Roein-peiker
CorrespondentBreanne Butler
Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston,  TX  77043
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2021-10-01

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