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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 K103474
Device Name ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
Applicant
Micerium S.P.A.
Via Marconi 83
Avegno, Genoa,  IT 16030
Applicant Contact SSA CARLA TAZZER
Correspondent
Micerium S.P.A.
Via Marconi 83
Avegno, Genoa,  IT 16030
Correspondent Contact SSA CARLA TAZZER
Regulation Number872.3770
Classification Product Code
EBG  
Date Received11/26/2010
Decision Date 02/07/2011
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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