Vatech Clismile

Bracket, Ceramic, Orthodontic

Rayence Co.,Ltd

The following data is part of a premarket notification filed by Rayence Co.,ltd with the FDA for Vatech Clismile.

Pre-market Notification Details

Device IDK220689
510k NumberK220689
Device Name:Vatech Clismile
ClassificationBracket, Ceramic, Orthodontic
Applicant Rayence Co.,Ltd 14, Samsung 1-ro, 1gil Hwaseong-si,  KR 445-170
ContactKevin Kim
CorrespondentDave Kim
Mtech Group 7505 Fannin St. Ste 610 Houston,  TX  77054
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-09
Decision Date2022-05-06

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