Dia-X Bond Universal

Agent, Tooth Bonding, Resin

Diadent Group International

The following data is part of a premarket notification filed by Diadent Group International with the FDA for Dia-x Bond Universal.

Pre-market Notification Details

Device IDK220804
510k NumberK220804
Device Name:Dia-X Bond Universal
ClassificationAgent, Tooth Bonding, 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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-18
Decision Date2022-06-15

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