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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K121621
Device Name SOLOCEM
Original Applicant
COLTENE/WHALEDENT AG
feldwiesenstrasse 20
altstatten,  SZ ch-9450
Original Contact silke wallaschek
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/01/2012
Decision Date 01/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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