Intraoral Sensor

Solid State X-ray Imager (flat Panel/digital Imager)

Dentium Co., Ltd (ICT Branch)

The following data is part of a premarket notification filed by Dentium Co., Ltd (ict Branch) with the FDA for Intraoral Sensor.

Pre-market Notification Details

Device IDK201247
510k NumberK201247
Device Name:Intraoral Sensor
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Dentium Co., Ltd (ICT Branch) 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si,  KR 16229
ContactSangwoo Lee
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200, V111 Houston,  TX  77054
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2020-06-10

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