Rainbow CT

X-ray, Tomography, Computed, Dental

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 Rainbow Ct.

Pre-market Notification Details

Device IDK200271
510k NumberK200271
Device Name:Rainbow CT
ClassificationX-ray, Tomography, Computed, Dental
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 CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2021-04-16


Device IdentifiersubmissionNumberSupplement
08809544906357 K200271 000

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