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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K163238
Device Name Eclipse Kiss Zirconia
Applicant
Ams
#530 Na-Dong Machzone, 117, Hwanggeum-Ro
Yangchon-Eup, Gimpo-Si
Gyeonggi-Do,  KR 10048
Applicant Contact HYUNA KIM
Correspondent
Onbix Corporation
#821 Samil. Plz., 837 -26 Yeuksam-Dong
Gangnam-Gu
Seoul,  KR 135768
Correspondent Contact HO DONG YANG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/18/2016
Decision Date 05/04/2017
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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