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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 K112710
Device Name ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
Original Applicant
WIELAND DENTAL + TECHNIK GMBH & CO. KG
schwenninger strabe 13
pforzheim,  GM d-75179
Original Contact gerhard polzer
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/19/2011
Decision Date 10/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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