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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K193623
Device Name DIOnavi-Denture
Applicant
Dio Corporation
66 Centumseo-Ro, Haeundae-Gu
Busan,  KR 48058
Applicant Contact Jiae Park
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/26/2019
Decision Date 10/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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