DENTIOIII Series (DENTIOIII, DENTIOIII-S)

System, X-ray, Extraoral Source, Digital

HDX WILL CORP.

The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Dentioiii Series (dentioiii, Dentioiii-s).

Pre-market Notification Details

Device IDK181297
510k NumberK181297
Device Name:DENTIOIII Series (DENTIOIII, DENTIOIII-S)
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactLee Myoung-joon
CorrespondentLee Myoung-joon
HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-16
Decision Date2018-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800005200120 K181297 000
08800005200113 K181297 000

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