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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 K153174
Device Name Ketac Universal Aplicap
Applicant
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82229
Applicant Contact RUEDIGER FRANKE
Correspondent
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82229
Correspondent Contact RUEDIGER FRANKE
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/03/2015
Decision Date 04/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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