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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 K123664
Device Name INCORIS ZI
Applicant
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE D-64625
Applicant Contact FRITZ KOLLE
Correspondent
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE D-64625
Correspondent Contact FRITZ KOLLE
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/28/2012
Decision Date 04/08/2013
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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