NEXCOMP AND META ETCHANT

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 Nexcomp And Meta Etchant.

Pre-market Notification Details

Device IDK080305
510k NumberK080305
Device Name:NEXCOMP AND META ETCHANT
ClassificationMaterial, Tooth Shade, Resin
Applicant META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHEONG JU Cheung City, Chung Buk,  KR 441-12
ContactTae-hoon Kim
CorrespondentTae-hoon Kim
META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHEONG JU Cheung City, Chung Buk,  KR 441-12
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-05
Decision Date2008-04-07
Summary:summary

NIH GUDID Devices

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