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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 K140836
Device Name ZIBONE ZIRCONIA BLOCKS
Applicant
Coho Technology Co., Ltd.
21 Dafeng St.
Luju Township
Taoyuan County,  TW 33860
Applicant Contact JACKY HSEIH
Correspondent
Coho Technology Co., Ltd.
21 Dafeng St.
Luju Township
Taoyuan County,  TW 33860
Correspondent Contact JACKY HSEIH
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/02/2014
Decision Date 06/17/2015
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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