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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
Applicant
Coltene/Whaledent AG
Feldwiesenstrasse 20
Altstatten,  CH CH-9450
Applicant Contact SILKE WALLASCHEK
Correspondent
Coltene/Whaledent AG
Feldwiesenstrasse 20
Altstatten,  CH CH-9450
Correspondent Contact SILKE WALLASCHEK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/01/2012
Decision Date 01/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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