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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K151144
Device Name SuPro 100
Applicant
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82234
Applicant Contact DESI W. SOEGIARTO
Correspondent
3M Deutschland GmbH
Espe Platz
Seefeld,  DE 82234
Correspondent Contact DESI W. SOEGIARTO
Regulation Number872.3770
Classification Product Code
EBG  
Date Received04/29/2015
Decision Date 09/14/2015
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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