DIAFIL & DIAFIL Capsule

Material, Tooth Shade, Resin

Diadent Group International

The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diafil & Diafil Capsule.

Pre-market Notification Details

Device IDK192510
510k NumberK192510
Device Name:DIAFIL & DIAFIL Capsule
ClassificationMaterial, Tooth Shade, Resin
Applicant Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si,  KR 28161
ContactKab Sun Lee
CorrespondentKab Sun Lee
Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si,  KR 28161
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-12
Decision Date2020-03-20

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