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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 K152118
Device Name Zenostar MT, Zenostar Color Liquids
Applicant
WIELAND DENTAL + TECHNIK GMBH & CO. KG
LINDERSTRASSE 2
PFOZHEIM,  DE 75179
Applicant Contact BETINA KISTNER
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/30/2015
Decision Date 12/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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