PreXion3D Explorer PRO

X-ray, Tomography, Computed, Dental

PreXion Corporation

The following data is part of a premarket notification filed by Prexion Corporation with the FDA for Prexion3d Explorer Pro.

Pre-market Notification Details

Device IDK221525
510k NumberK221525
Device Name:PreXion3D Explorer PRO
ClassificationX-ray, Tomography, Computed, Dental
Applicant PreXion Corporation 1-14-1, Kandasuda-cho Chiyoda-ku,  JP 101-0041
ContactHiroaki Takahashi
CorrespondentHiroaki Takahashi
PreXion Corporation 1-14-1, Kandasuda-cho Chiyoda-ku,  JP 101-0041
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-26
Decision Date2022-07-22

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