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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 K171876
Device Name Ceramill Zolid HT+ white
Applicant
Amann Girrbach AG
Herrschaftswiesen 1
Koblach,  AT 6842
Applicant Contact Debora Engel
Correspondent
Emergo Europe Consulting
Prinsessegracht 20
The Hague,  NL
Correspondent Contact Rachel Paul
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/23/2017
Decision Date 09/20/2017
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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