DiaPaste

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 Diapaste.

Pre-market Notification Details

Device IDK210333
510k NumberK210333
Device Name:DiaPaste
ClassificationResin, Root Canal Filling
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 CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-03-25

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.