Diapex Plus

Resin, Root Canal Filling

Diadent Group International

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

Pre-market Notification Details

Device IDK182625
510k NumberK182625
Device Name:Diapex Plus
ClassificationResin, Root Canal Filling
Applicant Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si,  KR 28161
ContactMyung Sub Kim
CorrespondentMyung Sub Kim
Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si,  KR 28161
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-24
Decision Date2019-06-03

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