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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 K190048
Device Name UF(II) Anatomic abutment
Applicant
Dio Corporation
66 Centumseo-Ro, Haeundae-Gu
Busan,  KR 48058
Applicant Contact Jiae Park
Correspondent
Dio USA
3470 Wilshire Blvd., #620
Los Angeles,  CA  90010
Correspondent Contact Peter Kang
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/10/2019
Decision Date 09/30/2019
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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