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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K182194
Device Name UV Active Implant System
Applicant
Dio Corporation
66 Centumseo-Ro, Haeundae-Gu
Busan,  KR 48058
Applicant Contact Park Jiae
Correspondent
Dio USA
3470 Wilshire Blvd., #620
Los Angeles,  CA  90010
Correspondent Contact Peter Kang
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/14/2018
Decision Date 12/14/2018
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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