Ezfil

Material, Tooth Shade, Resin

Meta Biomed Co., Ltd.

The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Ezfil.

Pre-market Notification Details

Device IDK191991
510k NumberK191991
Device Name:Ezfil
ClassificationMaterial, Tooth Shade, Resin
Applicant Meta Biomed Co., Ltd. 270, Osong Saengmyeong 1-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactSuk Song Oh
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-25
Decision Date2020-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806387894339 K191991 000
08806387894162 K191991 000
08806387894179 K191991 000
08806387894186 K191991 000
08806387894193 K191991 000
08806387894209 K191991 000
08806387894216 K191991 000
08806387894223 K191991 000
08806387894230 K191991 000
08806387894247 K191991 000
08806387894254 K191991 000
08806387894261 K191991 000
08806387894278 K191991 000
08806387894285 K191991 000
08806387894292 K191991 000
08806387894308 K191991 000
08806387894315 K191991 000
08806387894322 K191991 000
08806387894155 K191991 000

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