Material, Tooth Shade, Resin

Dentkist, Inc.

The following data is part of a premarket notification filed by Dentkist, Inc. with the FDA for Charmfil.

Pre-market Notification Details

Device IDK193496
510k NumberK193496
Device Name:CharmFil
ClassificationMaterial, Tooth Shade, Resin
Applicant Dentkist, Inc. 3, Nongshim-ro Gunpo-si,  KR 15842
ContactShin Haeng Lee
CorrespondentPeter Chung
Plus Global 300 Atwood St. Pittsburgh,  PA  15213
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-05-06

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