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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
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