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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 K161987
Device Name UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
Applicant
DIO CORPORATION
66, CENTUM SEO-RO
BUSAN,  KR 48058
Applicant Contact SANGIN PARK
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 Received07/19/2016
Decision Date 02/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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