DIA-ROOT BIO Sealer

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 Dia-root Bio Sealer.

Pre-market Notification Details

Device IDK200175
510k NumberK200175
Device Name:DIA-ROOT BIO Sealer
ClassificationResin, Root Canal Filling
Applicant Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si,  KR 28161
ContactKab Sun Lee
CorrespondentKab Sun Lee
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 Received2020-01-23
Decision Date2020-06-25

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.