Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart

X-ray, Tomography, Computed, Dental

VATECH CO., LTD

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Dental Computed Tomography X-ray System, Pht-30lfo, Pax-i3d Smart.

Pre-market Notification Details

Device IDK152106
510k NumberK152106
Device Name:Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
ClassificationX-ray, Tomography, Computed, Dental
Applicant VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL Hwaseong-si,  KR 445-170
ContactDaniel Kim
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-29
Decision Date2015-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800016400625 K152106 000
08800016400618 K152106 000

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