Resin, Denture, Relining, Repairing, Rebasing

DIO Corporation

The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dionavi-denture.

Pre-market Notification Details

Device IDK193623
510k NumberK193623
Device Name:DIOnavi-Denture
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant DIO Corporation 66, Centum Seo-ro, Haeundae-gu Busan,  KR 48058
ContactJiae Park
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-10-22

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