DiaTemp Flow

Crown And Bridge, Temporary, Resin

Diadent Group International

The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diatemp Flow.

Pre-market Notification Details

Device IDK192022
510k NumberK192022
Device Name:DiaTemp Flow
ClassificationCrown And Bridge, Temporary, Resin
Applicant Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactKab Sun Lee
CorrespondentKab Sun Lee
Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806383565776 K192022 000
08806383565769 K192022 000
08806383565592 K192022 000
08806383565585 K192022 000

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