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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K193404
Device Name UF(II) Bar holder abutment
Applicant
Dio Corporation
66 Centumseo-Ro, Haeundae-Gu
Busan,  KR 48058
Applicant Contact JiAe Park
Correspondent
Provision Consulting Group, Inc.
100 N Barranca St., Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/06/2019
Decision Date 05/18/2020
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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